Study Comparing the P200TxE and P200DTx

Optos

Status: Completed

Conditions: Retinal Disease

Treatments: Device: P200DTx; Device: P200TxE

Study type: Interventional

Funder types: Industry

Identifiers

NCT03964831

OPT1035

Details and patient eligibility

About

The study evaluates image quality between two devices.

Enrollment: 40 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 volunteer 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 in the study;
4. Subjects diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;

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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40 participants in 1 patient group

Ultra widefield image capture

Other group

Treatment:

Device: P200TxE

Device: P200DTx