[Trial of device that is not approved or cleared by the U.S. FDA]

[Redacted]1 site in 1 country40 target enrollmentMay 28, 2019

ConditionsRetinal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Retinal Disease
Sponsor: [Redacted]
Enrollment: 40
Locations: 1
Primary Endpoint: Qualitative Image assessment
Status: Withheld
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study evaluates image quality between two devices.

Registry

clinicaltrials.gov

Start Date

May 28, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

[Redacted]

Eligibility Criteria

Inclusion Criteria

•Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
•Subjects who can follow the instructions by the clinical staff at the clinical site,
•Subjects who agree to participate in the study;
•Subjects diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;

Exclusion Criteria

•Subjects unable to tolerate ophthalmic imaging;
•Subjects with ocular media not sufficiently clear to obtain acceptable images;

Outcomes

Primary Outcomes

Qualitative Image assessment

Time Frame: 6 months

Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3).

Safety Assessment from Adverse Events

Time Frame: 6 months

Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.