Navigated OCT Imaging With the P200TxE

Not Applicable

Completed

• Conditions: Retinal Disease

• Registration Number: NCT04003831
• Lead Sponsor: Optos, PLC

Brief Summary

The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study Start: 2019-06-13
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-01
• Primary Completion: 2020-12-16
• Study Completion: 2021-01-18
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Qualitative Assessment of OCT Clinical Utility	1 year	Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Qualitative Assessment of OCT Scan Quality	1 year	Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.

Secondary Outcome Measures

Name	Time	Method
Safety Assessment from Adverse Events	1 year	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)

Retina Consultants of San Diego; 🇺🇸 Poway, California, United States