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OpenTrials
Completed

NCT Number: NCT03964831

Study Comparing the P200TxE and P200DTx

The study evaluates image quality between two devices.

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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

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, 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 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

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

Treatment and study plan

P200TxE

Device

The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

P200DTx

Device

The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

Primary outcomes

  1. Qualitative Image assessment

    Time frame: 6 months

    Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3).

  2. Safety Assessment from Adverse Events

    Time frame: 6 months

    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

Visualization Study of the UWF (Ultra Wide-field) SLO (Scanning Laser Ophthalmoscope) RG (Red Green), AF (Autofluorescence), FA (Fluorescein Angiography) and ICG ( Indocyanine Green Fluorescence) Images Using the P200TxE (Indy) and P200DTx (California)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 28, 2019
Registry last updated
Sep 19, 2024

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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