Binocular Vision DisorderNCT03592615
Binocular Vision Anomalies After Cataract and Refractive Surgery
A study testing cataract surgery and Corneal refractive surgery in people with Binocular Vision Disorder and Refractive Errors, run by Salus University at 1 site in United States.
Trial summary
There are indications in the literature that binocular vision disorders may occur after cataract and corneal refractive surgery. It is not clear whether these problems are new or represent decompensation of previously existing conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binocular Vision Disorder, Refractive Errors, Cataract
- What is being tested?
- cataract surgery and Corneal refractive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract patients who are willing to undergo cataract extraction and intraocular lens implantation
- Refractive error patients who are willing to undergo laser corneal refractive surgery
- 18 years and older in cataract group
- 18-35 years old in refractive error group
- Any gender
- Any race or ethnicity
- Informed consent and willingness to participate in the study
Who cannot join
- Other ocular pathology that affect vision and binocular alignment in addition to cataract or refractive error
- Surgical complications that may affect binocular vision testing, such as a subluxation of the IOLs or macular edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Binocular Vision Anomalies Before and After Cataract and Refractive Surgery
There are indications in the literature that binocular vision disorders may occur after cataract and corneal refractive surgery. It is not clear whether these problems are new or represent decompensation of previously existing conditions. However, the following significant study limitations exist in the current literature: 1) lack of attention to non-strabismic binocular vision disorders, 2) incomplete binocular vision assessment, 3) a validated symptom survey was not used, 4) diplopia was typically the only symptom studied, 5) retrospective study design, and 6) in the few prospective studies the sample sizes were small.
Given the limitations in the current literature there is a need for further study of the prevalence and significance of binocular vision problems after cataract surgery and binocular vision and accommodative problems after corneal refractive surgery.
This study aims to determine whether there is an increase in the prevalence of binocular vision problems after cataract surgery and accommodative and binocular vision disorders after refractive surgery.
Read the detailed description
- Research plan Specific aim 1A: To investigate the prevalence of non-strabismic and strabismic binocular vision anomalies after cataract surgery. Specific aim 1B: To investigate the prevalence accommodative and binocular vision disorders after refractive surgery. Specific aim 2: To determine if increase in the prevalence of binocular anomalies is different for cataract surgery compared to refractive surgery. Specific aim 3: To develop an efficient examination protocol that would enable eye care professionals to determine if a patient is at risk for binocular vision anomalies after cataract surgery and accommodative and binocular vision disorders after refractive surgery. The proposed study will address the weaknesses in the current literature. The study will be prospective and will use explicit and well-defined eligibility and exclusion criteria. A comprehensive battery of accommodative (pre-presbyopes only) and binocular vision tests will be administered on all the patients before the surgery of the first eye and 12 weeks after the surgery of the second eye. A pre-defined classification protocol will be used to determine if a binocular vision disorder is present before surgery, after surgery, or whether there has been a change in the condition after surgery. A total prevalence of postoperative strabismic and non-strabismic binocular vision anomalies will be determined for the cataract population and the refractive error group.
- Statistical analysis plan 2.1 Specific aim 1A Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision anomalies after cataract surgery
A sample size calculation based on a McNemar's test to compare the prevalence of binocular vision anomalies before and after cataract surgery was performed using the Power and Sample Size Program (PS version 3.1.2). Base on a previous literature, the overall prevalence of accommodative and binocular vision anomalies in adult population (18-35 years) is 13.15%. However, no existing literature reported the prevalence of binocular vision anomalies after cataract surgery.
We propose that 15% increase in prevalence is clinically meaningful. The correlation between paired observations is 0.2, as recommended by Dupont. Although this is a large effect, the effect of cataract surgery on prevalence of binocular vision anomalies may be this large (presumed by an experienced binocular vision specialist). If the effect is smaller and the difference not statistically significant, the study will provide valuable data to plan another study. Therefore, a sample size calculation suggests that a total of 44 participants will yield a power of 80% with a significant level of 5%. To account for potential loss to follow-up, a sample size of 50 will be selected for the cataract group. All analyses will be performed using SPSS Statistics 24.0 with an alpha level of 0.05 to determine the statistical significance. A calculation for the prevalence of binocular vision anomalies before and after surgery will be performed. A two-tailed McNemar's Chi-Square Test will be used to test the statistical significance of the change in the proportion of binocular vision anomalies before and after surgery.
2.2 Specific aim 1B Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision and accommodative anomalies after refractive surgery.
The sample size calculation process for specific aim 1B was the same as for specific aim 1A. Therefore, a sample size of 50 will also be selected for the refractive error group. A calculation for the prevalence of accommodative and binocular vision anomalies before and after surgery will be performed. A two-tailed McNemar's Chi-Square Test will be used to test the statistical significance of the changes in the proportions of binocular vision anomalies before and after surgery.
2.3 Specific aim 2 Hypothesis: The increase in prevalence of binocular vision anomalies will be greater after cataract surgery than refractive surgery.
A calculation for the prevalence of binocular vision anomalies will be performed respectively in the cataract group and the refractive error group. A two-tailed Contingency Chi-Square Test will be used to test the statistical significance of difference of changes in the proportion of binocular vision anomalies before and after surgery in both groups.
2.4 Specific aim 3 Hypothesis: A short screening protocol will be of equal effectiveness to a comprehensive assessment of binocular vision and accommodation to determine which patients may be at risk for post-surgical binocular vision and accommodative anomalies.
A two-tailed MacNemar's Chi-Square Test will be used to test the statistical significance of difference in the effectiveness of a short screening protocol and a comprehensive assessment for determining the risk for post-surgical binocular vision and accommodative anomalies. Sensitivity and specificity for the short screening protocol will be calculated.
- Conditions
- Binocular Vision Disorder, Refractive Errors, Cataract
- Being tested
- cataract surgery, Corneal refractive surgery
- Keywords
- prevalence, binocular vision disorders, accommodative disorders, cataract surgery, corneal refractive surgery
- Medical subject headings
- Refractive Errors, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
Also called phacoemulsification, cataract extraction
Cataract surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than cataract, e.g., treatment for lens dislocation. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating astigmatism.
Corneal refractive surgeryProcedure or surgery
Also called LASIK, LASEK, PRK, SMILE
Corneal refractive surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than refractive error, e.g., treatment for corneal scar. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating severe astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Cataract group | Experimental | All participants in this arm undergo cataract surgery for the purpose of vision correction. Receives: Procedure: cataract surgery |
| Refractive error group | Experimental | All participants in this arm undergo corneal refractive surgery for the purpose of vision correction. Receives: Procedure: Corneal refractive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from pre-surgical phoria at 12 weeks post surgery
Phoria will be measured using cover test (in prism diopters).
Measured: Pre-surgery and 12 weeks post surgery
Changes from pre-surgical fusional vergence at 12 weeks post surgery
Fusional vergence will be measured using step vergence testing (in prism diopters).
Measured: Pre-surgery and 12 weeks post surgery
Changes from pre-surgical convergence amplitude at 12 weeks post surgery
Convergence amplitude will be measured using near point of convergence test (in centimeters).
Measured: Pre-surgery and 12 weeks post surgery
Changes from pre-surgical vergence facility at 12 weeks post surgery
Vergence facility will be measured using vergence facility testing (in cycle per minute).
Measured: Pre-surgery and 12 weeks post surgery
Changes from pre-surgical accommodative amplitude at 12 weeks post surgery (refractive error group only)
Accommodative amplitude will be measured using monocular amplitude of accommodation testing (in diopters).
Measured: Pre-surgery and 12 weeks post surgery
Changes from pre-surgical accommodative facility at 12 weeks post surgery (refractive error group only)
Accommodative facility will be measured using monocular accommodative facility testing (in cycle per minute).
Measured: Pre-surgery and 12 weeks post surgery
Secondary outcomes (3)
changes from pre-surgical stereopsis at 12 weeks post surgery
Randot stereo test (recorded in second of arc)
Measured: pre-surgery and 12 weeks post surgery
changes from pre-surgical aniseikonia at 12 weeks post surgery
Aniseikonia Inspector Software Program (recorded in percentage)
Measured: pre-surgery and 12 weeks post surgery
changes from pre-surgical CISS score at 12 weeks post surgery
Convergence insufficiency symptom survey (recorded in a summation of the CISS score). The CISS is a 15-items survey questioning the participants whether they have the symptoms related to binocular vision disorders. Each item has a scale ranging from 0 to 4, of which 0=never, 1=not very often, 2=sometimes, 3=fairly often, 4=always. A higher score indicates a worse outcome. The total score will be summed from the 15 items.
Measured: pre-surgery and 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start8 Jan 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Binocular Vision DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cataract group: participants undergo cataract surgery for vision correction Refractive error group: participants undergo corneal refractive surgery for vision correction
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-Qing Tan, Salus University
- Investigators
- Qing-Qing Tan, MSc, Principal investigator, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592615
- Sponsor's protocol ID
- qqt0001
- Status last verified
- Mar 2020
- First submitted
- 8 Jun 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minnal VR, Rosenberg JB. Refractive surgery: a treatment for and a cause of strabismus. Curr Opin Ophthalmol. 2011 Jul;22(4):222-5. doi: 10.1097/ICU.0b013e3283477c60.
PubMed 21537187Kalantzis G, Papaconstantinou D, Karagiannis D, Koutsandrea C, Stavropoulou D, Georgalas I. Post-cataract surgery diplopia: aetiology, management and prevention. Clin Exp Optom. 2014 Sep;97(5):407-10. doi: 10.1111/cxo.12197.
PubMed 25138745Gawecki M, Grzybowski A. Diplopia as the Complication of Cataract Surgery. J Ophthalmol. 2016;2016:2728712. doi: 10.1155/2016/2728712. Epub 2016 Feb 21.
PubMed 26998351Finlay AL. Binocular vision and refractive surgery. Cont Lens Anterior Eye. 2007 May;30(2):76-83. doi: 10.1016/j.clae.2007.02.009.
PubMed 17448926Loba P, Rajska K, Simiera J, Wilczynski M, Omulecki W, Broniarczyk-Loba A. The influence of a prolonged interoperative period on binocular vision after bilateral cataract extractions. Eur J Ophthalmol. 2015 Jul-Aug;25(4):315-9. doi: 10.5301/ejo.5000569. Epub 2015 Jan 27.
PubMed 25633621Rutstein RP, Fullard RJ, Wilson JA, Gordon A. Aniseikonia induced by cataract surgery and its effect on binocular vision. Optom Vis Sci. 2015 Feb;92(2):201-7. doi: 10.1097/OPX.0000000000000491.
PubMed 25546829Chung SA, Kim CY, Chang JH, Hong S, Kang SY, Seong GJ, Lee JB. Change in ocular alignment after topical anesthetic cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2009 Sep;247(9):1269-72. doi: 10.1007/s00417-009-1084-8. Epub 2009 Apr 30.
PubMed 19404663Golnik KC, West CE, Kaye E, Corcoran KT, Cionni RJ. Incidence of ocular misalignment and diplopia after uneventful cataract surgery. J Cataract Refract Surg. 2000 Aug;26(8):1205-9. doi: 10.1016/s0886-3350(00)00330-8.
PubMed 11008049Nayak H, Kersey JP, Oystreck DT, Cline RA, Lyons CJ. Diplopia following cataract surgery: a review of 150 patients. Eye (Lond). 2008 Aug;22(8):1057-64. doi: 10.1038/sj.eye.6702847. Epub 2007 Apr 27.
PubMed 17464297Karagiannis D, Chatzistefanou K, Damanakis A. Prevalence of diplopia related to cataract surgery among cases of diplopia. Eur J Ophthalmol. 2007 Nov-Dec;17(6):914-8. doi: 10.1177/112067210701700608.
PubMed 18050117Hutchinson AK. Refractive surgery for accommodative esotropia: past, present, and future. Eur J Ophthalmol. 2012 Nov-Dec;22(6):871-7. doi: 10.5301/ejo.5000210. Epub 2012 Oct 10.
PubMed 23097019Kirwan C, O'Keefe M, O'Mullane GM, Sheehan C. Refractive surgery in patients with accommodative and non-accommodative strabismus: 1-year prospective follow-up. Br J Ophthalmol. 2010 Jul;94(7):898-902. doi: 10.1136/bjo.2009.162420. Epub 2009 Nov 30.
PubMed 19948562Snir M, Kremer I, Weinberger D, Sherf I, Axer-Siegel R. Decompensation of exodeviation after corneal refractive surgery for moderate to high myopia. Ophthalmic Surg Lasers Imaging. 2003 Sep-Oct;34(5):363-70.
PubMed 14509458Kushner BJ, Kowal L. Diplopia after refractive surgery: occurrence and prevention. Arch Ophthalmol. 2003 Mar;121(3):315-21. doi: 10.1001/archopht.121.3.315.
PubMed 12617699Chung SA, Kim WK, Moon JW, Yang H, Kim JK, Lee SB, Lee JB. Impact of laser refractive surgery on ocular alignment in myopic patients. Eye (Lond). 2014 Nov;28(11):1321-7. doi: 10.1038/eye.2014.209. Epub 2014 Sep 5.
PubMed 25190533
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Binocular Vision Anomalies Before and After Cataract and Refractive Surgery
- ClinicalTrials.gov ID
- NCT03592615
- Acronym / sponsor ID
- qqt0001
- Conditions
- Binocular Vision Disorder, Refractive Errors, Cataract
- Keywords
- prevalence, binocular vision disorders, accommodative disorders, cataract surgery, corneal refractive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are indications in the literature that binocular vision disorders may occur after cataract and corneal refractive surgery. It is not clear whether these problems are new or represent decompensation of previously existing conditions. However, the following significant study limitations exist in the current literature: 1) lack of attention to non-strabismic binocular vision disorders, 2) incomplete binocular vision assessment, 3) a validated symptom survey was not used, 4) diplopia was typically the only symptom studied, 5) retrospective study design, and 6) in the few prospective studies the sample sizes were small.
Given the limitations in the current literature there is a need for further study of the prevalence and significance of binocular vision problems after cataract surgery and binocular vision and accommodative problems after corneal refractive surgery.
This study aims to determine whether there is an increase in the prevalence of binocular vision problems after cataract surgery and accommodative and binocular vision disorders after refractive surgery.
Detailed description
- Research plan Specific aim 1A: To investigate the prevalence of non-strabismic and strabismic binocular vision anomalies after cataract surgery. Specific aim 1B: To investigate the prevalence accommodative and binocular vision disorders after refractive surgery. Specific aim 2: To determine if increase in the prevalence of binocular anomalies is different for cataract surgery compared to refractive surgery. Specific aim 3: To develop an efficient examination protocol that would enable eye care professionals to determine if a patient is at risk for binocular vision anomalies after cataract surgery and accommodative and binocular vision disorders after refractive surgery. The proposed study will address the weaknesses in the current literature. The study will be prospective and will use explicit and well-defined eligibility and exclusion criteria. A comprehensive battery of accommodative (pre-presbyopes only) and binocular vision tests will be administered on all the patients before the surgery of the first eye and 12 weeks after the surgery of the second eye. A pre-defined classification protocol will be used to determine if a binocular vision disorder is present before surgery, after surgery, or whether there has been a change in the condition after surgery. A total prevalence of postoperative strabismic and non-strabismic binocular vision anomalies will be determined for the cataract population and the refractive error group.
- Statistical analysis plan 2.1 Specific aim 1A Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision anomalies after cataract surgery
A sample size calculation based on a McNemar's test to compare the prevalence of binocular vision anomalies before and after cataract surgery was performed using the Power and Sample Size Program (PS version 3.1.2). Base on a previous literature, the overall prevalence of accommodative and binocular vision anomalies in adult population (18-35 years) is 13.15%. However, no existing literature reported the prevalence of binocular vision anomalies after cataract surgery.
We propose that 15% increase in prevalence is clinically meaningful. The correlation between paired observations is 0.2, as recommended by Dupont. Although this is a large effect, the effect of cataract surgery on prevalence of binocular vision anomalies may be this large (presumed by an experienced binocular vision specialist). If the effect is smaller and the difference not statistically significant, the study will provide valuable data to plan another study. Therefore, a sample size calculation suggests that a total of 44 participants will yield a power of 80% with a significant level of 5%. To account for potential loss to follow-up, a sample size of 50 will be selected for the cataract group. All analyses will be performed using SPSS Statistics 24.0 with an alpha level of 0.05 to determine the statistical significance. A calculation for the prevalence of binocular vision anomalies before and after surgery will be performed. A two-tailed McNemar's Chi-Square Test will be used to test the statistical significance of the change in the proportion of binocular vision anomalies before and after surgery.
2.2 Specific aim 1B Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision and accommodative anomalies after refractive surgery.
The sample size calculation process for specific aim 1B was the same as for specific aim 1A. Therefore, a sample size of 50 will also be selected for the refractive error group. A calculation for the prevalence of accommodative and binocular vision anomalies before and after surgery will be performed. A two-tailed McNemar's Chi-Square Test will be used to test the statistical significance of the changes in the proportions of binocular vision anomalies before and after surgery.
2.3 Specific aim 2 Hypothesis: The increase in prevalence of binocular vision anomalies will be greater after cataract surgery than refractive surgery.
A calculation for the prevalence of binocular vision anomalies will be performed respectively in the cataract group and the refractive error group. A two-tailed Contingency Chi-Square Test will be used to test the statistical significance of difference of changes in the proportion of binocular vision anomalies before and after surgery in both groups.
2.4 Specific aim 3 Hypothesis: A short screening protocol will be of equal effectiveness to a comprehensive assessment of binocular vision and accommodation to determine which patients may be at risk for post-surgical binocular vision and accommodative anomalies.
A two-tailed MacNemar's Chi-Square Test will be used to test the statistical significance of difference in the effectiveness of a short screening protocol and a comprehensive assessment for determining the risk for post-surgical binocular vision and accommodative anomalies. Sensitivity and specificity for the short screening protocol will be calculated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cataract group: participants undergo cataract surgery for vision correction Refractive error group: participants undergo corneal refractive surgery for vision correction
| Arm | Type | Receives |
|---|---|---|
| Cataract group | Experimental | Procedure: cataract surgeryAll participants in this arm undergo cataract surgery for the purpose of vision correction. |
| Refractive error group | Experimental | Procedure: Corneal refractive surgeryAll participants in this arm undergo corneal refractive surgery for the purpose of vision correction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cataract patients who are willing to undergo cataract extraction and intraocular lens implantation
- Refractive error patients who are willing to undergo laser corneal refractive surgery
- 18 years and older in cataract group
- 18-35 years old in refractive error group
- Any gender
Key exclusion criteria (2 listed)
- Other ocular pathology that affect vision and binocular alignment in addition to cataract or refractive error
- Surgical complications that may affect binocular vision testing, such as a subluxation of the IOLs or macular edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgeryAlso: phacoemulsification, cataract extractionCataract surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than cataract, e.g., treatment for lens dislocation. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating astigmatism. | Procedure or surgery | Cataract group |
| Corneal refractive surgeryAlso: LASIK, LASEK, PRK, SMILECorneal refractive surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than refractive error, e.g., treatment for corneal scar. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating severe astigmatism. | Procedure or surgery | Refractive error group |
Primary outcome
Changes from pre-surgical phoria at 12 weeks post surgery
Time frame: Pre-surgery and 12 weeks post surgery
Phoria will be measured using cover test (in prism diopters).
Changes from pre-surgical fusional vergence at 12 weeks post surgery
Time frame: Pre-surgery and 12 weeks post surgery
Fusional vergence will be measured using step vergence testing (in prism diopters).
Changes from pre-surgical convergence amplitude at 12 weeks post surgery
Time frame: Pre-surgery and 12 weeks post surgery
Convergence amplitude will be measured using near point of convergence test (in centimeters).
Changes from pre-surgical vergence facility at 12 weeks post surgery
Time frame: Pre-surgery and 12 weeks post surgery
Vergence facility will be measured using vergence facility testing (in cycle per minute).
Changes from pre-surgical accommodative amplitude at 12 weeks post surgery (refractive error group only)
Time frame: Pre-surgery and 12 weeks post surgery
Accommodative amplitude will be measured using monocular amplitude of accommodation testing (in diopters).
Changes from pre-surgical accommodative facility at 12 weeks post surgery (refractive error group only)
Time frame: Pre-surgery and 12 weeks post surgery
Accommodative facility will be measured using monocular accommodative facility testing (in cycle per minute).
3 secondary outcomes
changes from pre-surgical stereopsis at 12 weeks post surgery
Time frame: pre-surgery and 12 weeks post surgery
changes from pre-surgical aniseikonia at 12 weeks post surgery
Time frame: pre-surgery and 12 weeks post surgery
changes from pre-surgical CISS score at 12 weeks post surgery
Time frame: pre-surgery and 12 weeks post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 21537187Minnal VR, Rosenberg JB. Refractive surgery: a treatment for and a cause of strabismus. Curr Opin Ophthalmol. 2011 Jul;22(4):222-5. doi: 10.1097/ICU.0b013e3283477c60.
- Background: PubMed 25138745Kalantzis G, Papaconstantinou D, Karagiannis D, Koutsandrea C, Stavropoulou D, Georgalas I. Post-cataract surgery diplopia: aetiology, management and prevention. Clin Exp Optom. 2014 Sep;97(5):407-10. doi: 10.1111/cxo.12197.
- Background: PubMed 26998351Gawecki M, Grzybowski A. Diplopia as the Complication of Cataract Surgery. J Ophthalmol. 2016;2016:2728712. doi: 10.1155/2016/2728712. Epub 2016 Feb 21.
- Background: PubMed 17448926Finlay AL. Binocular vision and refractive surgery. Cont Lens Anterior Eye. 2007 May;30(2):76-83. doi: 10.1016/j.clae.2007.02.009.
- Background: PubMed 25633621Loba P, Rajska K, Simiera J, Wilczynski M, Omulecki W, Broniarczyk-Loba A. The influence of a prolonged interoperative period on binocular vision after bilateral cataract extractions. Eur J Ophthalmol. 2015 Jul-Aug;25(4):315-9. doi: 10.5301/ejo.5000569. Epub 2015 Jan 27.
- Background: PubMed 25546829Rutstein RP, Fullard RJ, Wilson JA, Gordon A. Aniseikonia induced by cataract surgery and its effect on binocular vision. Optom Vis Sci. 2015 Feb;92(2):201-7. doi: 10.1097/OPX.0000000000000491.
- Background: PubMed 19404663Chung SA, Kim CY, Chang JH, Hong S, Kang SY, Seong GJ, Lee JB. Change in ocular alignment after topical anesthetic cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2009 Sep;247(9):1269-72. doi: 10.1007/s00417-009-1084-8. Epub 2009 Apr 30.
- Background: PubMed 11008049Golnik KC, West CE, Kaye E, Corcoran KT, Cionni RJ. Incidence of ocular misalignment and diplopia after uneventful cataract surgery. J Cataract Refract Surg. 2000 Aug;26(8):1205-9. doi: 10.1016/s0886-3350(00)00330-8.
- Background: PubMed 17464297Nayak H, Kersey JP, Oystreck DT, Cline RA, Lyons CJ. Diplopia following cataract surgery: a review of 150 patients. Eye (Lond). 2008 Aug;22(8):1057-64. doi: 10.1038/sj.eye.6702847. Epub 2007 Apr 27.
- Background: PubMed 18050117Karagiannis D, Chatzistefanou K, Damanakis A. Prevalence of diplopia related to cataract surgery among cases of diplopia. Eur J Ophthalmol. 2007 Nov-Dec;17(6):914-8. doi: 10.1177/112067210701700608.
- Background: PubMed 23097019Hutchinson AK. Refractive surgery for accommodative esotropia: past, present, and future. Eur J Ophthalmol. 2012 Nov-Dec;22(6):871-7. doi: 10.5301/ejo.5000210. Epub 2012 Oct 10.
- Background: PubMed 19948562Kirwan C, O'Keefe M, O'Mullane GM, Sheehan C. Refractive surgery in patients with accommodative and non-accommodative strabismus: 1-year prospective follow-up. Br J Ophthalmol. 2010 Jul;94(7):898-902. doi: 10.1136/bjo.2009.162420. Epub 2009 Nov 30.
- 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.
Qing-Qing Tan, MSc principal investigator
Salus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery and Corneal refractive surgery in people with Binocular Vision Disorder and Refractive Errors, run by Salus University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from pre-surgical phoria at 12 weeks post surgery (time frame: Pre-surgery and 12 weeks post surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592615, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.