P200TxE Diseased Eye Image Collection

Not Applicable

Recruiting

• Conditions: Retinal Disease
• Interventions: Device: P200TxE

• Registration Number: NCT06269666
• Lead Sponsor: Optos, PLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging Session	P200TxE	Various scans will be captured

Primary Outcome Measures

Name	Time	Method
Number of images	1 year

Trial Locations

Locations (1)

Bennett and Bloom Eye Centers; 🇺🇸 Louisville, Kentucky, United States