Actively Recruiting
Performance Evaluation of Dream OCT: AP Study
Led by Intalight, Inc · Updated on 2026-01-21
120
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
I
Intalight, Inc
Lead Sponsor
I
Illinois College of Optometry
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.
CONDITIONS
Official Title
Performance Evaluation of Dream OCT: AP Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 22 years of age or older at the time of consent
- Be able to understand and willing to sign the informed consent
- For Normal Group: Have normal eye exams in both eyes with best corrected visual acuity (BCVA) of 20/40 or better
- For Glaucoma Group: Have BCVA 20/40 or better in the study eye and documented glaucoma-related visual field defects and optic nerve damage
- For Retina Disease Group: Have BCVA 20/400 or better in the study eye and diagnosed retinal pathology such as macular degeneration, diabetic retinopathy, or others
- For Cornea Group: Have BCVA 20/400 or better in the study eye and one or more corneal abnormalities such as corneal disease, keratoconus, cornea transplant, post refractive surgery, dry eye syndrome, or long-term contact lens use
You will not qualify if you...
- Unable to tolerate ophthalmic imaging
- Unable to obtain acceptable OCT images due to eye media opacity or other reasons
- Have any condition or situation that may put the subject at significant risk, confound study results, or interfere with participation
- For Normal Group: Have any ocular pathology except cataract
- For Glaucoma Group: No reliable visual field test result within the past year or poor test reliability
- For other groups: Conditions that prevent safe or reliable imaging or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Actively Recruiting
Research Team
M
Mike Sinai, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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