Data Collection With the P200TE and P200TxE

Optos

Status: Terminated

Conditions: Retinal Disease

Treatments: Device: Imaging Session

Study type: Interventional

Funder types: Industry

Identifiers

NCT05615896

OPT1037

Details and patient eligibility

About

The primary objective is to collect OCT scans on a modified P200TxE and P200TE.

Enrollment: 5 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

P200TxE Device First

Experimental group

Treatment:

Device: Imaging Session

P200TE Device First

Experimental group

Treatment:

Device: Imaging Session