Data Collection With the P200TE and P200TxE

Sponsor
Optos, PLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT05615896
Collaborator
(none)
5
1
2
13.8
0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Imaging Session
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
AA
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
Actual Study Start Date :
Apr 22, 2021
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Jun 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: P200TxE Device First

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

Experimental: P200TE Device First

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

Outcome Measures

Primary Outcome Measures

  1. Collection of images [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retina Consultants of Texas Research Centers Houston Texas United States 77401

Sponsors and Collaborators

  • Optos, PLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Optos, PLC
ClinicalTrials.gov Identifier:
NCT05615896
Other Study ID Numbers:
  • OPT1037
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022