P200TxE Diseased Eye Image Collection

Optos

Status: Enrolling

Conditions: Retinal Disease

Treatments: Device: P200TxE

Study type: Interventional

Funder types: Industry

Identifiers

NCT06269666

OPT1100

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Imaging Session

Other group

Description:

Various scans will be captured

Treatment:

Device: P200TxE