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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Retinal Disease Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All patients

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

Group Type OTHER

P200TE

Intervention Type DEVICE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Spectral OCT/SLO

Intervention Type DEVICE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Interventions

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P200TE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Intervention Type DEVICE

Spectral OCT/SLO

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No