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

Last updated: August 4, 2025
Sponsor: Cylite Pty Ltd
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Investigational Biometer

IOLMaster 700 Biometer

Clinical Study ID

NCT06826599
CYC-CL-SOP-004
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and sign an Institution Review Board approved Informed Consentform.

  • 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 groupsidentified in the protocol.

Exclusion

Exclusion Criteria:

  • 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 mayinterfere 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.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Investigational Biometer
Phase:
Study Start date:
January 18, 2025
Estimated Completion Date:
March 30, 2025

Study Description

This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.

Connect with a study center

  • NorthEast Eye Research Associates LLC

    Woburn, Massachusetts 01801
    United States

    Site Not Available

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