Back to resultsData Collection With the P200TE and P200TxE
Primary Purpose
Retinal Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaging Session
Sponsored by
About this trial
This is an interventional other trial for Retinal Disease
Eligibility Criteria
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.
Sites / Locations
- Retina Consultants of Texas Research Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
P200TxE Device First
P200TE Device First
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05615896
Brief Title
Data Collection With the P200TE and P200TxE
Official Title
Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
The study is no longer required.
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
June 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optos, PLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to collect OCT scans on a modified P200TxE and P200TE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P200TxE Device First
Arm Type
Experimental
Arm Title
P200TE Device First
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Imaging Session
Intervention Description
Various scans will be captured on both devices
Primary Outcome Measure Information:
Title
Collection of images
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Retina Consultants of Texas Research Centers
City
Houston
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Data Collection With the P200TE and P200TxE
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