Image Evaluation of Intalight Dream OCTA Scans With Optos FA & ICGA Images

Conditions

• Retina Pathology

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dream OCT — DEVICE
  This study employs the Dream OCT to image the eyes of patients with retina pathology

Study Details

The goal of this study is to evaluate the image quality and clinical utility of the OCTA images from the VG200D OCT device (investigational device) compared against the FA and ICGA images from the UWF Optos California (CA) device. Image assessment will be conducted by three expert image graders and involve the assessment of the images based on both image quality and clinical utility. Evidence for substantial equivalence will be obtained through establishing similar image evaluation results across the devices based on image quality and clinical utility.

Key Dates

Start date

Mar 25, 2026

Status verified

Apr 2026

Primary completion

Jul 15, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: Eyes with retina pathology
  These are eyes with some type of retina pathology such as age-related macular degeneration, diabetic retinopathy, diabetic macula edema, and other retina pathologies

Primary Outcome Measure

Image assessment of retinal images [ Time Frame: All images and clinical study data will be collected in one clinical visit, which typically should take approximately 1 hour. ]

Central Contacts

• Mike Sinai, PhD
  6198067636
  [email protected]

Locations (1)

Find similar trials in Houston, TX