Recruiting

P200TE & Spectral OCT/SLO

Sponsor:

Optos, PLC

Code:

NCT02921568

Conditions

Retinal Disease

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

P200TE

Spectral OCT/SLO

Study Details

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.

Conditions

Retinal Disease

Glaucoma

Study ID

NCT02921568

Start date

Sep, 2016

Status verified date

Sep, 2016

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: All patients

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

Interventions

P200TE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Spectral OCT/SLO

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Primary outcome measure

  • retinal thickness [ Time Frame: completion of the study, up to 5 years ]
  • Retinal Nerve Fibre Layer Thickness [ Time Frame: completion of the study, up to 5 years ]
  • Optic Nerve Head Topography [ Time Frame: completion of the study, up to 5 years ]
  • Cup/Disc Ratio [ Time Frame: completion of the study, up to 5 years ]

Central Contacts and Locations

Locations

Medical Center Ophthalmology Associates

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Principal Investigator:

Michael Singer, MD

More Information

Sponsor

Optos, PLC

Last update posted

Mar 14, 2017

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Optos, PLC on 2017-03-14.