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NCT05615896 Clinical Trial

Data Collection With the P200TE and P200TxE

Retinal Disease Clinical Trial

Official title:
Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05615896
Other study ID # OPT1037
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 22, 2021
Est. completion date June 17, 2022

Study information
Verified date March 2024
Source Optos, PLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to collect OCT scans on a modified P200TxE and P200TE.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date June 17, 2022
Est. primary completion date April 28, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria : - Male or female volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed; - Volunteers who can follow the instructions by the clinical staff at the clinical site; - Volunteers who agree to participate; - Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region. Exclusion Criteria: - Volunteers unable to tolerate ophthalmic imaging; - Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Imaging Session
Various scans will be captured on both devices

Locations
Country Name City State
United States Retina Consultants of Texas Research Centers Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collection of images The primary endpoint will be the collection of OCT scans on the P200TE and P200TxE devices. The scans will be used by R&D for development of a de-noising algorithm as well as other possible developments. 1 year
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