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Completed

NCT Number: NCT03912584

Study Comparing the P200TE and the P200TxE in Glaucoma Patients

The study evaluates the image quality between two OCT devices.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

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

About this study

The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.

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 who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;

Exclusion criteria

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  • Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
  • Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%;
  • Subjects with history of dementia or multiple sclerosis

Treatment and study plan

P200TE

Device

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one 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 B-Scan Assessment

    Time frame: 1 day (start: April 29, 2019 - completed: April 30, 2019)

    Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good.

    The four point scale is defined as follows:

    0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan.

    • indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility.
    • indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility.
    • indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 1 day

    Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study.

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Registry information

Official study title

Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Sep 23, 2022

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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