Assessment of Measurement Variability Across Automated Biometry Devices

Completed

• Conditions: Myopia
• Interventions: Diagnostic Test: Orbscan II; Diagnostic Test: IOL Master 700; Diagnostic Test: IOL Master 500; Diagnostic Test: Atlas 9000; Diagnostic Test: Lenstar 900; Diagnostic Test: Pentacam; Diagnostic Test: iTrace; Diagnostic Test: Argos; Diagnostic Test: Manual caliper measurement

• Registration Number: NCT06045325
• Lead Sponsor: Berkeley Eye Center

Brief Summary

This is a non-interventional prospective, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers.

Detailed Description

This is a non-interventional prospective, single center, bilateral, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers. Additional biometric devices or external photography may be included as well.

Study Timeline

• Study Start: 2023-07-25
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Results First Submitted: 2025-03-28
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Results First Posted: 2025-05-13
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Adults ages 18-50 years of age with healthy eyes and no prior ocular surgery
2. At least -1.00 of myopia (spherical equivalent)
3. Able to comprehend and willing to sign informed consent and consent and complete all required testing procedures
4. Clear intraocular media

Exclusion Criteria

1. Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
2. History of or current retinal conditions or predisposition to retinal conditions
3. Amblyopia or strabismus in either eye
4. History of or current anterior or posterior segment inflammation of any etiology
5. Any form of neovascularization on or within the eye
6. Glaucoma (uncontrolled or controlled with medication)
7. Optic nerve atrophy
8. Subjects with diagnosed degenerative eye disorders
9. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. connective tissue disease, immunocompromised, clinically significant atopic disease, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myopic -1.00D	Manual caliper measurement	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	Orbscan II	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	Atlas 9000	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	IOL Master 700	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	Lenstar 900	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	iTrace	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	Argos	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	IOL Master 500	Myopic patients with a diopter of at least -1.00
Myopic -1.00D	Pentacam	Myopic patients with a diopter of at least -1.00

Primary Outcome Measures

Name	Time	Method
The Correlation of White-to-white Measurements Between Biometric Devices.	Day of visit	The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II.
The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.	Day of visit	The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II.
The Correlation of Corneal Thickness Measurements Between Biometric Devices.	Day of visit	The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II.

Trial Locations

Locations (1)

Berkeley Eye Center; 🇺🇸 Houston, Texas, United States