Data Collection With the P200TE and P200TxE
March 8, 2024 updated by: Optos, PLC
Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
The primary objective is to collect OCT scans on a modified P200TxE and P200TE.
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77401
- Retina Consultants of Texas Research Centers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: P200TxE Device First
|
Various scans will be captured on both devices
|
|
Experimental: P200TE Device First
|
Various scans will be captured on both devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collection of images
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2021
Primary Completion (Actual)
April 28, 2021
Study Completion (Actual)
June 17, 2022
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
November 8, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPT1037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.