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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02921568

Enrollment

Registered

2016-10-03

Start date

2016-09-30

Completion date

Unknown

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Retinal Disease

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.

Interventions

DEVICEP200TE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

DEVICESpectral OCT/SLO

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026