Reference database of normal eyes using the VG200D OCT
Official title: Intalight Reference Database Protocol for VG200D
Run by Intalight, Inc · NCT07751484 · Data updated 2026-11-12
This study tests whether the VG200D OCT device can create a reference database of normal eye measurements from healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Intalight, Inc Industry-sponsored |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Status | Recruiting |
| Started | July 8, 2026 |
| Main results expected | September 15, 2026 |
| Study ends | September 15, 2026 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07751484 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22 and older with normal eyes who can undergo ophthalmic imaging and consent to participate, from diverse ethnic backgrounds.
✕Probably not a fit
Individuals with ocular pathologies beyond mild peripheral changes or cataracts, or with glaucoma, may not benefit from this reference database.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects VG200D OCT and OCTA scans from healthy eyes across three U.S. clinics to build a reference database of normal measurements. It aims to estimate distribution curves and non-parametric cut-offs (1%, 5%, 95%, 99%) for each parameter, to help clinicians interpret VG200D output. Enrollment targets include at least 350 eyes from a diverse age range, with data used to color-code measurements as within normal limits, borderline, or outside normal limits. The reference database is intended to assist clinical interpretation when using the device, in combination with other clinical information.
Why it matters
Potential benefit: If successful, clinicians may have a validated reference framework to interpret VG200D measurements and identify deviations from normal in individual patients.
How similar studies have gone: Similar observational efforts have established normative OCT databases and supported device-specific reference ranges in other settings, though this study focuses on the VG200D.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Subject 22 years of age or older on the date of informed consent 2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with normal eyes. Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed. 4\. BCVA 20/40 or better (each eye) 5. Subject is able to comply with the study procedures Exclusion Criteria: * 1\. Subject unable to tolerate ophthalmic imaging 2. Subject has an ocular pathology other than cataract or mild peripheral, age-related changes (e.g., peripheral drusen, lattice, etc.) 3. Glaucoma diagnosis in either eye. 4. 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 5. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
Where it's running
-
New View Optometry
San Diego, California, United States Recruiting -
Illinois College of Optometry
Chicago, Illinois, United States Recruiting -
Indiana University - School of Optometry
Bloomington, Indiana, United States Recruiting
Study contacts
- Study coordinator: Mike Sinai, PhD
- Email: mike.sinai@gmail.com
- Phone: 6198067636
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.