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

NCT06826599 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2025-08-05

No results posted yet for this 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.

Conditions

  • Normal Eyes
  • Abnormal Eyes

Interventions

DEVICE

Investigational Biometer

Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters

DEVICE

IOLMaster 700 Biometer

Commercially available non-contact instrument used to capture optical biometry measurements

Sponsors & Collaborators

  • Cylite Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Arnold Ouyang, PhD · Cylite Pty Ltd

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-18
Primary Completion
2025-03-30
Completion
2025-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06826599 on ClinicalTrials.gov