P200TxE Diseased Eye Image Collection

Retinal Disease Clinical Trial

Official title:

P200TxE Diseased Eye Image Collection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269666
• Other study ID #: OPT1100
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Optos, PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to collect images on the P200TxE device in diseased eyes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed;

2. Subjects who can follow the instructions by the clinical staff at the clinical site;

3. Subjects who agree to participate;

4. Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.

For glaucoma subjects:

a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;

2. Subjects with ocular media not sufficiently clear to obtain acceptable images.

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Device:
• P200TxE
SLO and OCT imaging

Locations

Country	Name	City	State
United States	Bennett and Bloom Eye Centers	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of images		1 year