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OpenTrials
Completed

NCT Number: NCT04003831

Navigated OCT Imaging With the P200TxE

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

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Key information

Conditions

Retinal Disease Eye Diseases Retinal Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Retina Consultants of San Diego

Poway, California, 92064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Subjects who can follow the instructions by the clinical staff at the clinical site,
  • Subjects who agree to participate in the study;
  • Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.

Exclusion criteria

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

Treatment and study plan

Device: P200TxE

Device

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

Primary outcomes

  1. Qualitative Assessment of OCT Clinical Utility

    Time frame: 1 year

    Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.

  2. Qualitative Assessment of OCT Scan Quality

    Time frame: 1 year

    Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.

Secondary outcomes

  1. Safety Assessment from Adverse Events

    Time frame: 1 year

    Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Registry information

Official study title

Navigated Peripheral OCT Imaging With the P200TxE

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 1, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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