Navigated OCT Imaging With the P200TxE

NCT ID: NCT04003831

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2021-01-18

Brief Summary

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The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.

Detailed Description

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Conditions

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Retinal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Optical Coherence Tomographer

Group Type OTHER

Device: P200TxE

Intervention Type DEVICE

The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Interventions

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Device: P200TxE

The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Intervention Type DEVICE

Eligibility Criteria

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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 presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Optos, PLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retina Consultants of San Diego

Poway, California, United States

Site Status

Countries

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United States

Other Identifiers

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OPT1033

Identifier Type: -

Identifier Source: org_study_id

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