Intalight Reference Database Protocol for VG200D
Intalight, Inc
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.
Description
The goal of this study is to capture VG200D OCT and OCTA scans on at least 350 normal, healthy eyes from individuals with an average age between 55-60 years of age that come from a wide range of ethnicities and races to roughly approximate the US population. This data will be used to create distribution curves for each measurement parameter and to determine the cut-off values at the 1%, 5%, 95% and 99% values for each measurement parameter. Cut-off values will be determined using a non-parametric method based on the distribution directly. Each measurement parameter distribution and associated…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
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. S…
Interventions
- DeviceOCT device called VG200D
This is an investigational imaging device
Locations (3)
- New View OptometrySan Diego, California
- Illinois College of OptometryChicago, Illinois
- Indiana University - School of OptometryBloomington, Indiana