Agreement and Precision Study of UNITY® DX and a Comparator Biometer

Completed

Conditions studied: Normal Eyes, Abnormal Eyes

In brief

The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the biometric measurements will be evaluated.

Key facts

Study ID

NCT06826599

Run by

Cylite Pty Ltd

People needed

160

Starts

2025-01-18

Expected to finish

2025-03-30

Last updated by the study team

2025-08-05

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand and sign an Institution Review Board approved Informed Consent form.
• Willing and able to attend all scheduled study visits as required by the protocol.
• Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.

You may not qualify if…

• Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
• Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
• Active ocular infection or inflammation.
• Rigid or contact lens wear during the previous two weeks prior to Screening.

Where it is running

• NorthEast Eye Research Associates LLC — Woburn, Massachusetts, United States

Full record on ClinicalTrials.gov

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