Intalight Reference Database Protocol for VG200D

NCT07751484 | Recruiting FDA Device

• 1 other identifier: DREAM-RDB1-2026-003
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to collect OCT scans on normal healthy eyes from an investigational OCT device the VG200D from Intalight, Inc, in order to establish a reference database. The reference database will be used to establish normal ranges for thickness measurement parameters provided by the VG200D OCT software including anterior segment and posterior segment measurements. The study will enroll normal eyes from three clinics in the US including a wide range of ages and races/ethnicities.

Conditions

The Focus of This Study is to Collect OCT Data on Normal Eyes

Keywords

Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Quantitative ocular structures

  Retinal structural measurements of the anterior and posterior segments of the eye

  this study will alst approximately 6 months

Study Arms (1)

Normal

This group includes subjects with normal healthy eyes as confirmed by a clinical examination by trained eye-care professionals

Device: OCT device called VG200D

Interventions

OCT device called VG200D DEVICE

This is an investigational imaging device

Normal

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of approximately 350 subjects without ocular pathology will be enrolled in this study from 3 clinical sites. Subjects will include a diverse range of races and ethnicities and should reflect or generally approximate the general population of the US. The average age of all subjects will be approximately 55-60 years of age or older. The age distribution will be similar to the table below. Percent 5 10 20 25 25 15 Total # 18 35 70 87 88 52 Age 22-30 31-40 41-50 51-60 61-70 71+ Table1. The age distribution of the study participants along with the percentage for each age group and the total number of subjects for each age group to be enrolled. The following seven categories on race and ethnicity were identified and defined and will be used in this study\*: * American Indian or Alaska Native * Asian * Black or African American * Hispanic or Latino * Middle Eastern or North African * Native Hawaiian or Pacific Islander * White

You may qualify if:

• \. 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.
• \. BCVA 20/40 or better (each eye) 5. Subject is able to comply with the study procedures

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Intalight, Inc: lead
• Illinois College of Optometry: collaborator

Study Sites (3)

New View Optometry

San Diego, California, 91942, United States

RECRUITING

Illinois College of Optometry

Chicago, Illinois, 60616, United States

RECRUITING

Indiana University - School of Optometry

Bloomington, Indiana, 47405, United States

RECRUITING

Central Study Contacts

Mike Sinai, PhD

CONTACT

6198067636; mike.sinai@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)