NCT06045325

Assessment of Measurement Variability Across Automated Biometry Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 204 (actual)
• Sponsor: Berkeley Eye Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Orbscan II	Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TEST	IOL Master 700	Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TEST	IOL Master 500	Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TEST	Atlas 9000	Diagnostic assessment to measure white-to-white.
DIAGNOSTIC_TEST	Lenstar 900	Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TEST	Pentacam	Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TEST	iTrace	Diagnostic assessment to measure white-to-white and corneal thickness.
DIAGNOSTIC_TEST	Argos	Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TEST	Manual caliper measurement	Manual diagnostic assessment to measure white-to-white.

Timeline

• Start date: 2023-07-25
• Primary completion: 2024-02-16
• Completion: 2024-02-16
• First posted: 2023-09-21
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study