NCT06826599

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Cylite Pty Ltd · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Normal Eyes
• Abnormal Eyes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-18
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2025-02-14
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study