Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

An Observational Multicenter Clinical Study to Provide Additional Long-Term Follow-up Beyond 60 Months for Subjects Implanted With a CyPass Micro-Stent in the COMPASS Trial

ClinicalTrials.gov ID

NCT04629521

Acronym / sponsor ID

COMPASS XXT / GLD122-P004

Conditions

Primary Open Angle Glaucoma, Cataract

Study type

Interventional

Recruitment status

Completed

Enrolment

54 participants (actual)

Lead sponsor

Alcon ResearchIndustry (pharma, biotech, devices)

Study start

21 Dec 2020 (actual)

Primary completion

5 Apr 2023 (actual)

Study completion

5 Apr 2023 (actual)

First posted

16 Nov 2020 (actual)

Results

Posted 26 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Other

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

45 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Eyes With Sight-threatening Adverse Events (AEs)

   Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative

   An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes sight-threatening adverse events as specified in the protocol. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

2. Percentage of Eyes With Ocular Adverse Events

   Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative

   An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes ocular events other than sight-threatening adverse events. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

3. Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation

   Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

   Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

4. Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval

   Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

   Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

5. Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)

   Time frame: Month 96 (Year 8) postoperative

   Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

6. Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)

   Time frame: Month 108 (Year 9) postoperative

   Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

7. Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)

   Time frame: Month 120 (Year 10) postoperative

   Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

8. Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation

   Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

   Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

9. Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval

   Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

   Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

10. Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)

    Time frame: Month 96 (Year 8) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

11. Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)

    Time frame: Month 108 (Year 9) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

12. Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)

    Time frame: Month 120 (Year 10) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

13. Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation

    Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

14. Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8)

    Time frame: Month 96 (Year 8) postoperative

    The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

15. Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9)

    Time frame: Month 108 (Year 9) postoperative

    The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

16. Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10)

    Time frame: Month 120 (Year 10) postoperative

    The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

17. Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation

    Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

18. Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8)

    Time frame: Month 96 (Year 8) postoperative

    The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

19. Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9)

    Time frame: Month 108 (Year 9) postoperative

    The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

20. Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10)

    Time frame: Month 120 (Year 10) postoperative

    The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

21. Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

22. Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

23. Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

24. Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)

    Time frame: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

25. Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)

    Time frame: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

26. Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

27. Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

28. Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

29. Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)

    Time frame: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

30. Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)

    Time frame: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

31. Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared

    Time frame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

32. Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared

    Time frame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

33. Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline

    Time frame: Baseline (COMPASS Study) preoperative, Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

34. Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared

    Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

35. Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared

    Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

36. Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation

    Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

37. Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval

    Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

38. Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation

    Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

39. Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval

    Time frame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

40. Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL)

    Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Corneal sequelae are occurrences of complications related to ECL in the cornea and may include corneal edema, decreased visual acuity, corneal decompensation, bullous keratopathy, etc. Corneal sequelae were quantified by counting the instances where patients experienced complications attributable to endothelial cell loss. A higher number of corneal sequelae events may indicate rapid disease progression or inadequate management of conditions leading to endothelial cell loss. A lower number of corneal sequelae events may indicate a favorable response to treatment and successful disease treatment or treatment stabilization. This analysis was performed using data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

41. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation

    Time frame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10)

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

42. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3

    Time frame: Month 3 postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

43. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6

    Time frame: Month 6 postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

44. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1)

    Time frame: Month 12 (Year 1) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

45. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2)

    Time frame: Month 24 (Year 2) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

46. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3)

    Time frame: Month 36 (Year 3) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

47. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4)

    Time frame: Month 48 (Year 4) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

48. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5)

    Time frame: Month 60 (Year 5) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

49. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)

    Time frame: Month 96 (Year 8) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

50. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)

    Time frame: Month 108 (Year 9) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

51. Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)

    Time frame: Month 120 (Year 10) postoperative

    Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

52. Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation

    Time frame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

53. Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)

    Time frame: Month 96 (Year 8) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

54. Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)

    Time frame: Month 108 (Year 9) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

55. Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)

    Time frame: Month 120 (Year 10) postoperative

    Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

56. Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation)

    Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative

    SSI events are additional surgical procedures performed after the initial placement of the CyPass micro-stent device to adjust its position or address issues related to its placement. SSI were noted through adverse event reporting, clinical evaluation, comprehensive documentation of outcome assessment and data analysis. A higher number of SSI events may indicate challenges or complications related to the initial placement of the CyPass device, technical difficulties during the initial surgery, device-related issues, or patient-specific factors contributing to the need for additional interventions. A lower number of SSI events may suggest that the initial device placement was successful and well-tolerated, with fewer complications or the need for adjustments. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

57. Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition

    Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative

    CyPass micro-stent movement and/or malposition refers to issues related to the displacement or improper positioning of the CyPass Micro-Stent in the eye's drainage angle. The investigator qualitatively and subjectively assessed the position of the device by counting the visible number of rings of the device during a gonioscopic exam, which used a specialized lens to visually assess the position and stability of the CyPass device. Movement and/or malposition may suggest a greater risk of complications or inadequate treatment of glaucoma. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

58. Number of Corneal Adverse Events Caused by CyPass MicroStent

    Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative

    A corneal adverse event is an undesirable occurrence related to the cornea, such as inflammation, edema, epithelial defects, or other complications. The number of corneal adverse events caused by the CyPass Micro-Stent was assessed from patient reporting, clinical observation and documentation during patients' follow-up visits. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

59. Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More

    Time frame: Month 96 (Year 8) to Month 120 (Year 10) postoperative

    Visual acuity was measured with correction in place using letter charts. BCVA [synonymous with Best Corrected Distance Visual Acuity (BCDVA)] at each visit was compared to the participant's best achieved BCVA recorded throughout the 10-year period after CyPass implantation. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

60. Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation

    Time frame: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 Swedish Interactive Thresholding Algorithm (SITA) standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

61. Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB)

    Time frame: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 SITA standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

62. Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

63. Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval

    Time frame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

    CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

12 sites in 1 country: see every site and its status.