Study Evaluating Retinal Health Monitoring System Thickness Module

February 18, 2021 updated by: Kubota Vision Inc.

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema

Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).

Study Overview

Status

Withdrawn

Detailed Description

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.

Study Type

Observational

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

    • California
      • Sacramento, California, United States, 95819
        • Retinal Consultants Medical Group, Inc

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects aged ≥ 18 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.

Description

Inclusion Criteria:

  1. Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
  2. Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
  3. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
  4. Able and willing to give informed consent
  5. Group 1:

    1. Macula with normal thickness [central subfield thickness (CST) below 305 microns as measured by SD-OCT] in at least one eye
    2. Patients with dry AMD are eligible for enrollment into Group 1
    3. No history of wet AMD, DR, or RVO in either eye
  6. Group 2 and Group 3 (in at least one or the same eye):

    1. History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
    2. Macular edema on SD-OCT with CST ≥ 305 microns

Exclusion Criteria:

  1. History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
  2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
  3. Participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening
  4. Refractive error: spherical equivalent of > 3 diopters of hyperopia or > 6 diopters of myopia, or > 2 diopters cylinder in the study eye(s)
  5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Subjects with normal macular thickness in one or both eyes.
Assessment of retinal thickness.
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)
Assessment of retinal structure.
Group 2
Subjects with center-involving macular edema due to w/AMD in one or both eyes.
Assessment of retinal thickness.
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)
Assessment of retinal structure.
Group 3
Subjects with center-involving macular edema due to DR or RVO in one or both eyes.
Assessment of retinal thickness.
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)
Assessment of retinal structure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the RHMS-RTM retinal thickness measurements
Time Frame: 1 day
To evaluate the ability of the RHMS-RTM device to measure retinal thickness
1 day
RHMS-RTM repeatability
Time Frame: 1 day
To assess repeatability of the RHMS-RTM device
1 day
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
Time Frame: 1 month
To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT
1 month

Collaborators and Investigators

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

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 (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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