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

Not Applicable

• Conditions: Retinal Disease
• Interventions: Device: P200TxE; Device: P200DTx

• Registration Number: NCT03964831
• Lead Sponsor: [Redacted]

Brief Summary

The study evaluates image quality between two devices.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-28
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: WITHHELD
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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;
2. Subjects who can follow the instructions by the clinical staff at the clinical site,
3. Subjects who agree to participate in the study;
4. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultra widefield image capture	P200TxE	-
Ultra widefield image capture	P200DTx	-

Primary Outcome Measures

Name	Time	Method
Qualitative Image assessment	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	6 months	Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.

Trial Locations

Locations (1)

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States