Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam

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:

1. 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)
2. To compare the agreement of Cylinder magnitude and axis between IOLMaster 700 SW Version 1.70 and Pentacam
3. To evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers. 1.70 for all measurement parameters listed above

Study Overview

• Status: Completed
• Conditions: Cornea
• Intervention / Treatment: Device: Biometry

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77027
      • Slade & Baker Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Male or Female 22 years of age and older.
2. 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.
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.
5. 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.
6. 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.
7. Group 3: history of Laser Vision Correction (LVC).

Exclusion Criteria:

1. Previous intraocular surgery other than Laser Vision Correction in the study eye.
2. Previous corneal surgery other than Laser Vision Correction in the study eye.
3. Presence of any corneal or retinal abnormality on slit lamp examination in the study eye.
4. Corneal Cylinder < 0.75D measured with a IOLMaster.
5. Active ocular infection or inflammation.
6. Poor tear film/insufficient corneal reflex.
7. Best corrected visual acuity worse than 20/200 in the study eye.
8. Physical inability to be positioned at the slit-lamp biomicroscope or study devices (e.g. torticollis, head tremor, etc.).
9. Insufficient eyelid opening or eyelashes which partially conceal alignment or keratometry reflections and prevent capture of all measurements.
10. Inability to fixate (e.g. due to nystagmus, amblyopia or ocular disease, such as macular degeneration).
11. Rigid contact lens wear during past two weeks.
12. Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRFs).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Biometry; Measurement of Cornea
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.	Device: Biometry; Measurement of Cornea
Post LVC Eyes; History of Laser Vision Correction (LVC)	Device: Biometry; Measurement of Cornea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 hour
Repeatability and Reproducibility of IOLMaster 700 Software Version 700 Measurements.	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.	1 hour

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec, Inc.
• Collaborators: ClinReg Consulting Services, Inc.; Sierra Clinical Services, LLC
• Investigators: Principal Investigator: Stephen Slade, MD, Slade & Baker Vision

Publications and helpful links

General Publications

• Lu 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.
• 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.
• Baumeister 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IOLMaster 2017-01909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No