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

NCT07568704 | Recruiting FDA Device

• 1 other identifier: DREAM-CP2026-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retina Pathology

Outcome Measures

Primary Outcomes (1)

• Image assessment of retinal images

  The outcome measure is the image grading of retinal images including OCTA and FA and or ICGA images as graded by experts

  All images and clinical study data will be collected in one clinical visit, which typically should take approximately 1 hour.

Study Arms (1)

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

Device: Dream OCT

Interventions

Dream OCT DEVICE

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

Eyes with retina pathology

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with retina pathology

You may qualify if:

• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• BCVA 20/400 or better in the study eye
• Diagnosis of retinal associated pathology by investigator with the need to have an FA and/or ICGA performed in at least one eye

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging
• Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
• Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Sponsors & Collaborators

• Intalight, Inc: lead

Study Sites (1)

Retina Consultants of Texas

Houston, Texas, 77401, United States

RECRUITING

Central Study Contacts

Mike Sinai, PhD

CONTACT

6198067636; mike.sinai@intalight.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 6, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)