UNITY DX Cornea Study

Conditions

• Tomography

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• UNITY DX — DEVICE
  Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
• ANTERION — DEVICE
  Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties

Study Details

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 corneal and epithelial thickness maps will be evaluated.

Key Dates

First listed

Aug 17, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

110 participants (estimated)

Arms

• Arm: Normal Corneas
  The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with normal corneas.
• Arm: Keratoconus
  The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with keratoconus.
• Arm: Prior Corneal Laser Vision Correction
  The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with prior corneal laser vision correction.
• Arm: Current and Habitual Contact Lens Wear
  The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with current and habitual contact lens wear.
• Arm: Dry Eye
  The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with dry eye.

Primary Outcome Measure

Mean corneal thickness [ Time Frame: Day 1 ]

Central Contacts

• Alcon Call Center
  1-888-451-3937
  [email protected]

Locations (1)

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