Performance Evaluation of Dream OCT: AP Study
Intalight, Inc
Summary
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.
Description
The goal of this study is to 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. Evidence for substantial equivalence will be through establishing equivalent precision results between devices and meeting pre-determined performance goals for precision and agreement results for a majority of parameters. The primary objective of this study is to evaluate agreement and…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for Normal Group: 1. Subjects 22 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens 4. BCVA 20/40 or better (each eye) on the date of the study visit Exclusion Criteria for Normal Group: 1. Subjects unable to tolerate ophthalmic imaging 2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or ot…
Interventions
- DeviceThis is an observational study only, all patients are imaged on the investigational device
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device
Location
- Illinois College of OptometryChicago, Illinois