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

Not Applicable

• Conditions: Retinal Disease; Glaucoma
• Interventions: Device: P200TE; Device: Spectral OCT/SLO

• Registration Number: NCT02921568
• Lead Sponsor: Optos, PLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
2. Subjects who have signed the informed consent;
3. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
4. Subjects who agree to participate in the study;
5. Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
6. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	P200TE	All patients will be imaged on the P200TE and Spectral OCT/SLO devices.
All patients	Spectral OCT/SLO	All patients will be imaged on the P200TE and Spectral OCT/SLO devices.

Primary Outcome Measures

Name	Time	Method
Optic Nerve Head Topography	completion of the study, up to 5 years
retinal thickness	completion of the study, up to 5 years
Cup/Disc Ratio	completion of the study, up to 5 years
Retinal Nerve Fibre Layer Thickness	completion of the study, up to 5 years

Trial Locations

Locations (1)

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States