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
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

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