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Evaluation of the Retinal Health Monitoring System Thickness Module

Sponsor
Kubota Vision Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04499703
Collaborator
(none)
60
Enrollment
1
Location
2.5
Actual Duration (Months)
24.4
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 :
60 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
Actual Study Start Date :
Nov 11, 2020
Actual Primary Completion Date :
Jan 25, 2021
Actual Study Completion Date :
Jan 25, 2021

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 wAMD 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

    Secondary Outcome Measures

    1. Repeatability of RHMS-RTM retina thickness measurements [1 day]

      To assess repeatability of the RHMS-RTM device

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

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

    3. Intraretinal and subretinal fluid detection [1 day]

      To evaluate the feasibility of intra- and sub-retinal fluid detection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age ≥50.

    2. Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)

    3. Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)

    4. Able to perform self-testing of retinal thickness with the RHMS-RTM after training

    5. Able and willing to provide written informed consent before undergoing any study-related procedures

    6. Group 1: Macula with normal thickness [central subfield thickness (CST): <305μm in women, and <320μm in men as measured by Heidelberg Spectralis SD-OCT in at least one eye. Patients diagnosed with dry AMD are eligible for enrollment into Group 1. No history of wAMD, DR, or RVO in either eye

    7. Group 2 and Group 3, in at least one and the same eye: History of center-involving macular edema due to wAMD (Group 2); or DR or RVO (Group 3); Macular edema on SD-OCT with CST ≥305 μm in women, and ≥320μm in men as measured by Heidelberg Spectralis SD-OCT.

    Exclusion Criteria:

    1. History of corneal refractive surgery [e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)] in the study eye(s)

    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 of screening or an investigational device within 60 days of screening

    4. Refractive error within defined limits

    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 Inselspital, University Hospital Bern, Department of Ophthalmology Bern Switzerland 3010

    Sponsors and Collaborators

    • Kubota Vision Inc.

    Investigators

    • Principal Investigator: Marion Munk, MD, PhD, Inselspital, University Hospital Bern

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kubota Vision Inc.
    ClinicalTrials.gov Identifier:
    NCT04499703
    Other Study ID Numbers:
    • SCT-202 D
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Kubota Vision Inc.
    Age-Related Macular Degeneration
    macular edema
    retinal vein occlusion
    diabetic macular edema
    Additional relevant MeSH terms:
    Macular Degeneration
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Feb 18, 2021