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Study Evaluating Retinal Health Monitoring System Thickness Module

Sponsor
Kubota Vision Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04428242
Collaborator
(none)
0
Enrollment
1
Location
3
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: RHMS-RTM
  • Diagnostic Test: SD-OCT

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 Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Group 1

Subjects with normal macular thickness in one or both eyes.

Device: RHMS-RTM
Assessment of retinal thickness.
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)

    • Diagnostic Test: SD-OCT
    Assessment of retinal structure.
    Group 2

    Subjects with center-involving macular edema due to w/AMD in one or both eyes.

    Device: RHMS-RTM
    Assessment of retinal thickness.
    Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)

    • Diagnostic Test: SD-OCT
    Assessment of retinal structure.
    Group 3

    Subjects with center-involving macular edema due to DR or RVO in one or both eyes.

    Device: RHMS-RTM
    Assessment of retinal thickness.
    Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)

    • Diagnostic Test: SD-OCT
    Assessment of retinal structure.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the RHMS-RTM retinal thickness measurements [1 day]

      To evaluate the ability of the RHMS-RTM device to measure retinal thickness

    2. RHMS-RTM repeatability [1 day]

      To assess repeatability of the RHMS-RTM device

    3. Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT [1 month]

      To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    6. Macula with normal thickness [central subfield thickness (CST) below 305 microns as measured by SD-OCT] in at least one eye

    7. Patients with dry AMD are eligible for enrollment into Group 1

    8. No history of wet AMD, DR, or RVO in either eye

    9. Group 2 and Group 3 (in at least one or the same eye):

    10. History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)

    11. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants Medical Group, Inc Sacramento California United States 95819

    Sponsors and Collaborators

    • Kubota Vision Inc.

    Investigators

    • Study Director: Jeff Gregory, MD, Kubota Vision Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kubota Vision Inc.
    ClinicalTrials.gov Identifier:
    NCT04428242
    Other Study ID Numbers:
    • SCT-202
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Kubota Vision Inc.
    Macular Edema, Wet AMD
    Retinal Thickness
    Diabetic Retinopathy, Retinal Vein Occlusion
    Additional relevant MeSH terms:
    Macular Degeneration
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Feb 21, 2021