Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes

Optos

Status

Unknown

Conditions

Glaucoma

Retinal Disease

Treatments

Device: Spectral OCT/SLO

Device: P200TE

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02921568

OPT1018

Details and patient eligibility

About

This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
Subjects who have signed the informed consent;
Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
Subjects who agree to participate in the study;
Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.

Exclusion criteria

Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
Subjects with history of leukemia, dementia or multiple sclerosis.