Performance Evaluation of Dream OCT: AP Study

Conditions

• Eyes With Corneal Abnormality
• Glaucoma Patients
• Normal Healthy Eyes
• Retina Patients

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• This is an observational study only, all patients are imaged on the investigational device — DEVICE
  This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device

Study Details

This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.

Key Dates

Start date

Dec 16, 2025

Status verified

Jan 2026

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: Normal Healthy Eyes
  Eyes without pathology
• Arm: Glaucoma
  Patients with glaucoma in one or both eyes
• Arm: Retina
  Patients with retina pathology in one or both eyes
• Arm: Cornea
  Eyes with cornea abnormality in one or both eyes

Primary Outcome Measure

Agreement results and Precision Results [ Time Frame: This study will last approximately 6 months ]

Central Contacts

• Mike Sinai, PhD
  6198067636
  [email protected]

Locations (1)

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