Study Stopped
The study is no longer required.
Data Collection With the P200TE and P200TxE
1 other identifier
interventional
5
1 country
1
Brief Summary
The primary objective is to collect OCT scans on a modified P200TxE and P200TE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedFirst Submitted
Initial submission to the registry
June 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedMarch 12, 2024
March 1, 2024
6 days
June 21, 2021
March 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
P200TxE Device First
EXPERIMENTALP200TE Device First
EXPERIMENTALInterventions
Various scans will be captured on both devices
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Volunteers unable to tolerate ophthalmic imaging;
- Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Optos, PLClead
Study Sites (1)
Retina Consultants of Texas Research Centers
Houston, Texas, 77401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2021
First Posted
November 14, 2022
Study Start
April 22, 2021
Primary Completion
April 28, 2021
Study Completion
June 17, 2022
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share