CorneaNCT03518775
Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam
An observational study of Cornea, run by Carl Zeiss Meditec, Inc. at 1 site in United States.
Trial summary
The objectives of this study are to determine the agreement of measurements between the IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 and Pentacam, as well as to evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers 1.70. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cornea
- What is being tested?
- Biometry
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 20 Apr 2018
- Phase
- Observational
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: There will be three cohorts: normal eyes (Group 1), cataract eyes (Group 2), and post Laser Vision Correction (LVC) eyes (Group 3), with no cross-over between the study groups.
Who may be able to join
- Male or Female 22 years of age and older.
- No history of rigid contact lens wear for at least 2 weeks. Soft lenses, if worn, should be removed at least one hour prior to the measurement.
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
- Group 1: normal eyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the LOCS III system, and no prior Laser Vision Correction.
- Group 2: cataract in the study eye greater than Grade 1 using the LOCS III system for one or more: nuclear opacity, nuclear color, cortical opacity, or PSC.
- Group 3: history of Laser Vision Correction (LVC).
Who cannot join
- Previous intraocular surgery other than Laser Vision Correction in the study eye.
- Previous corneal surgery other than Laser Vision Correction in the study eye.
- Presence of any corneal or retinal abnormality on slit lamp examination in the study eye.
- Corneal Cylinder < 0.75D measured with a IOLMaster.
- Active ocular infection or inflammation.
- Poor tear film/insufficient corneal reflex.
Show all 12Show fewer
- Best corrected visual acuity worse than 20/200 in the study eye.
- Physical inability to be positioned at the slit-lamp biomicroscope or study devices (e.g. torticollis, head tremor, etc.).
- Insufficient eyelid opening or eyelashes which partially conceal alignment or keratometry reflections and prevent capture of all measurements.
- Inability to fixate (e.g. due to nystagmus, amblyopia or ocular disease, such as macular degeneration).
- Rigid contact lens wear during past two weeks.
- Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRFs).
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to determine the agreement of measurements between the IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 and Pentacam, as well as to evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers 1.70.
The following parameters will be evaluated for Total Keratometry, (TK) and Posterior Corneal Surface (PCS):
Read more
- cylinder (CYL), Axis (A)
- spherical equivalent (SE)
Specific Objectives:
- To compare the agreement of SE between IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 (Carl Zeiss Meditec AG, Jena, Germany)
- To compare the agreement of Cylinder magnitude and axis between IOLMaster 700 SW Version 1.70 and Pentacam
- To evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers. 1.70 for all measurement parameters listed above
- Conditions
- Cornea
- Being tested
- Biometry
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiometryDevice
Measurement of Cornea
| Study group | Role | What they receive |
|---|---|---|
| Normal Eyes | Eyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the LOCS III system, and no prior Laser Vision Correction. Receives: Device: Biometry | |
| Cataract Eyes | Cataract in the study eye greater than Grade 1 using the LOCS III system for one or more: nuclear opacity, nuclear color, cortical opacity, or PSC. Receives: Device: Biometry | |
| Post LVC Eyes | History of Laser Vision Correction (LVC) Receives: Device: Biometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Agreement between IOL Master Software Versions 1.70 and 1.50.
IOLMaster 700 Vers. 1.70 SE_TK (Spherical Equivalent_Total Keratometry) Measurements will be compared to IOLMaster 700 SW Vers. 1.50 SE_K (Spherical Equivalent_Keratometry) Measurements for Agreement.
Measured: 1 hour
Measurement Agreement between IOLMaster Software Version 1.70 and Pentacam.
IOLMaster 700 Vers. 1.70 A_TK (Axis_Total Keratometry), Cyl_TK (Cylinder_Total Keratometry), A_PCS (Axis_Posterior Corneal Surface), SE_PCS (Spherical Equivalent_Posterior Corneal Surface), and Cyl_PCS (Cylinder_Posterior Corneal Surface) Measurements will be compared to Pentacam Measurements for Agreement.
Measured: 1 hour
Repeatability and Reproducibility of IOLMaster 700 Software Version 700 Measurements.
- Evaluate the Repeatability and Reproducibility of the IOLMaster 700 SW Version 1.70 for A_TK, A_PCS, Cyl_TK, Cyl_PCS, SE_TK and SE_PCS.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start16 Mar 2018
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CorneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinReg Consulting Services, Inc., Sierra Clinical Services, LLC
- Responsible party
- Sponsor
- Investigators
- Stephen Slade, MD, Principal investigator, Slade & Baker Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518775
- Sponsor's protocol ID
- IOLMaster 2017-01909
- Status last verified
- May 2018
- First submitted
- 6 Apr 2018
- Last updated
- 31 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vogel A, Dick HB, Krummenauer F. Reproducibility of optical biometry using partial coherence interferometry : intraobserver and interobserver reliability. J Cataract Refract Surg. 2001 Dec;27(12):1961-8. doi: 10.1016/s0886-3350(01)01214-7.
PubMed 11738911Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039.
PubMed 27838682Baumeister M, Terzi E, Ekici Y, Kohnen T. Comparison of manual and automated methods to determine horizontal corneal diameter. J Cataract Refract Surg. 2004 Feb;30(2):374-80. doi: 10.1016/j.jcrs.2003.06.004.
PubMed 15030827
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam
- ClinicalTrials.gov ID
- NCT03518775
- Acronym / sponsor ID
- IOLMaster 2017-01909
- Conditions
- Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinReg Consulting Services, Inc., Sierra Clinical Services, LLC
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 8 May 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.
The objectives of this study are to determine the agreement of measurements between the IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 and Pentacam, as well as to evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers 1.70.
The following parameters will be evaluated for Total Keratometry, (TK) and Posterior Corneal Surface (PCS):
- cylinder (CYL), Axis (A)
- spherical equivalent (SE)
Specific Objectives:
- To compare the agreement of SE between IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 (Carl Zeiss Meditec AG, Jena, Germany)
- To compare the agreement of Cylinder magnitude and axis between IOLMaster 700 SW Version 1.70 and Pentacam
- To evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers. 1.70 for all measurement parameters listed above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Eyes | – | Device: BiometryEyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the LOCS III system, and no prior Laser Vision Correction. |
| Cataract Eyes | – | Device: BiometryCataract in the study eye greater than Grade 1 using the LOCS III system for one or more: nuclear opacity, nuclear color, cortical opacity, or PSC. |
| Post LVC Eyes | – | Device: BiometryHistory of Laser Vision Correction (LVC) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There will be three cohorts: normal eyes (Group 1), cataract eyes (Group 2), and post Laser Vision Correction (LVC) eyes (Group 3), with no cross-over between the study groups.
Key inclusion criteria (7 listed)
- Male or Female 22 years of age and older.
- No history of rigid contact lens wear for at least 2 weeks. Soft lenses, if worn, should be removed at least one hour prior to the measurement.
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
- Group 1: normal eyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the LOCS III system, and no prior Laser Vision Correction.
Key exclusion criteria (12 listed)
- Previous intraocular surgery other than Laser Vision Correction in the study eye.
- Previous corneal surgery other than Laser Vision Correction in the study eye.
- Presence of any corneal or retinal abnormality on slit lamp examination in the study eye.
- Corneal Cylinder < 0.75D measured with a IOLMaster.
- Active ocular infection or inflammation.
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 |
|---|---|---|
| BiometryMeasurement of Cornea | Device | Cataract Eyes, Normal Eyes, Post LVC Eyes |
Primary outcome
Measurement Agreement between IOL Master Software Versions 1.70 and 1.50.
Time frame: 1 hour
IOLMaster 700 Vers. 1.70 SE_TK (Spherical Equivalent_Total Keratometry) Measurements will be compared to IOLMaster 700 SW Vers. 1.50 SE_K (Spherical Equivalent_Keratometry) Measurements for Agreement.
Measurement Agreement between IOLMaster Software Version 1.70 and Pentacam.
Time frame: 1 hour
IOLMaster 700 Vers. 1.70 A_TK (Axis_Total Keratometry), Cyl_TK (Cylinder_Total Keratometry), A_PCS (Axis_Posterior Corneal Surface), SE_PCS (Spherical Equivalent_Posterior Corneal Surface), and Cyl_PCS (Cylinder_Posterior Corneal Surface) Measurements will be compared to Pentacam Measurements for Agreement.
Repeatability and Reproducibility of IOLMaster 700 Software Version 700 Measurements.
Time frame: 1 hour
3. Evaluate the Repeatability and Reproducibility of the IOLMaster 700 SW Version 1.70 for A_TK, A_PCS, Cyl_TK, Cyl_PCS, SE_TK and SE_PCS.
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 31 May 2018.
- Background: PubMed 11738911Vogel A, Dick HB, Krummenauer F. Reproducibility of optical biometry using partial coherence interferometry : intraobserver and interobserver reliability. J Cataract Refract Surg. 2001 Dec;27(12):1961-8. doi: 10.1016/s0886-3350(01)01214-7.
- Background: PubMed 27838682Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039.
- Background: PubMed 15030827Baumeister M, Terzi E, Ekici Y, Kohnen T. Comparison of manual and automated methods to determine horizontal corneal diameter. J Cataract Refract Surg. 2004 Feb;30(2):374-80. doi: 10.1016/j.jcrs.2003.06.004.
- 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.
Stephen Slade, MD principal investigator
Slade & Baker Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cornea, run by Carl Zeiss Meditec, Inc. 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 12 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 31 May 2018. 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?
Measurement Agreement between IOL Master Software Versions 1.70 and 1.50. (time frame: 1 hour). The study lists 3 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 NCT03518775, which also lists 3 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 31 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.