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

Status unconfirmed · Not applicable

Conditions studied: Retinal Disease, Glaucoma

In brief

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.

Key facts

Study ID

NCT02921568

Run by

Optos, PLC

People needed

20

Starts

2016-09-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Center Ophthalmology Associates — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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