Navigated OCT Imaging With the P200TxE

Retinal Disease Clinical Trial

Official title:

Navigated Peripheral OCT Imaging With the P200TxE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003831
• Other study ID #: OPT1033
• Status: Completed
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: January 18, 2021

Study information

• Verified date: March 2021
• Source: Optos, PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 18, 2021
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Device:
• Device: P200TxE
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Locations

Country	Name	City	State
United States	Retina Consultants of San Diego	Poway	California

Sponsors (1)

Lead Sponsor	Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Assessment of OCT Clinical Utility	Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.	1 year
Primary	Qualitative Assessment of OCT Scan Quality	Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.	1 year
Secondary	Safety Assessment from Adverse Events	Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.	1 year