Skip to main content
OpenTrials
Completed

NCT Number: NCT06045325

Assessment of Measurement Variability Across Automated Biometry Devices

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Berkeley Eye Center

Houston, Texas, 77027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • History of or current retinal conditions or predisposition to retinal conditions
  • Amblyopia or strabismus in either eye
  • History of or current anterior or posterior segment inflammation of any etiology
  • Any form of neovascularization on or within the eye
  • Glaucoma (uncontrolled or controlled with medication)
  • Optic nerve atrophy
  • Subjects with diagnosed degenerative eye disorders
  • 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.)

Treatment and study plan

Orbscan II

Diagnostic Test

Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

IOL Master 700

Diagnostic Test

Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

IOL Master 500

Diagnostic Test

Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Atlas 9000

Diagnostic Test

Diagnostic assessment to measure white-to-white.

Lenstar 900

Diagnostic Test

Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Pentacam

Diagnostic Test

Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

iTrace

Diagnostic Test

Diagnostic assessment to measure white-to-white and corneal thickness.

Argos

Diagnostic Test

Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Manual caliper measurement

Diagnostic Test

Manual diagnostic assessment to measure white-to-white.

Primary outcomes

  1. The Correlation of White-to-white Measurements Between Biometric Devices.

    Time frame: Day of visit

    The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II.

  2. The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.

    Time frame: Day of visit

    The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II.

  3. The Correlation of Corneal Thickness Measurements Between Biometric Devices.

    Time frame: Day of visit

    The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II.

Sponsors and collaborators

Lead sponsor

Berkeley Eye Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.