Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes

March 13, 2017 updated by: Optos, PLC
This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Medical Center Ophthalmology Associates
        • Sub-Investigator:
          • James Burns, MD
        • Sub-Investigator:
          • Richard Evans, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
  2. Subjects who have signed the informed consent;
  3. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  4. Subjects who agree to participate in the study;
  5. Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
  6. Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.

Exclusion Criteria:

  1. Subjects unable to tolerate ophthalmic imaging;
  2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  3. Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
  4. Subjects with history of leukemia, dementia or multiple sclerosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: All patients
All patients will be imaged on the P200TE and Spectral OCT/SLO devices.
Device: P200TE
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
Device: Spectral OCT/SLO
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
retinal thickness
Time Frame: completion of the study, up to 5 years
completion of the study, up to 5 years
Retinal Nerve Fibre Layer Thickness
Time Frame: completion of the study, up to 5 years
completion of the study, up to 5 years
Optic Nerve Head Topography
Time Frame: completion of the study, up to 5 years
completion of the study, up to 5 years
Cup/Disc Ratio
Time Frame: completion of the study, up to 5 years
completion of the study, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optos, PLC

Collaborators

Optos, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (ESTIMATE)

October 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT1018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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