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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921568
• Other study ID #: OPT1018
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2016
• Last updated: March 13, 2017
• Start date: September 2016

Study information

• Verified date: September 2016
• Source: Optos, PLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Retinal Disease
• Retinal Diseases

Intervention

Device:
• P200TE
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
• Spectral OCT/SLO
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

Locations

Country	Name	City	State
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Optos, PLC.	Optos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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