Recruiting

OCTA vs. UWF Optos

Sponsor:

Intalight, Inc

Code:

NCT07568704

Conditions

Retina Pathology

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Dream OCT

Study Details

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

Study ID

NCT07568704

Start date

Mar 25, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Dream OCT

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

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 and Locations

Central contacts

Mike Sinai, PhD

6198067636mike.sinai@intalight.com

Locations

Retina Consultants of Texas

Recruiting

Houston, Texas, United States, 77401

Contacts

rebbecca Taing, BS

713-394-7576rebbecca.taing@retinaconsultantstexas.com

Principal Investigator:

David Brown, MD

More Information

Sponsor

Intalight, Inc

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Intalight, Inc on 2026-05-06.