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

Completed

• Conditions: Cornea
• Interventions: Device: Biometry

• Registration Number: NCT03518775
• Lead Sponsor: Carl Zeiss Meditec, Inc.

Brief 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.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Study First Submitted: 2018-04-06
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Study First Submitted QC: 2018-04-25
• Status Verified: 2018-05
• Study First Posted: 2018-05-08
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Eyes	Biometry	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.
Post LVC Eyes	Biometry	History of Laser Vision Correction (LVC)
Cataract Eyes	Biometry	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.

Primary Outcome Measures

Name	Time	Method
Measurement Agreement between IOLMaster Software Version 1.70 and Pentacam.	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.
Measurement Agreement between IOL Master Software Versions 1.70 and 1.50.	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.
Repeatability and Reproducibility of IOLMaster 700 Software Version 700 Measurements.	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.

Trial Locations

Locations (1)

Slade & Baker Vision; 🇺🇸 Houston, Texas, United States