Assessment of Measurement Variability Across Automated Biometry Devices

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.

Conditions

• Myopia

Interventions

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.

Sponsors & Collaborators

• Berkeley Eye Center

  lead OTHER

Principal Investigators

• Morgan Micheletti, MD · Berkeley Eye Center

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-25

Primary Completion

2024-02-16

Completion

2024-02-16

FDA Device

Yes

Countries

• United States

Study Locations