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Study Evaluating Retinal Health Monitoring System Thickness Module

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428242
Recruitment Status : Withdrawn (COVD-19)
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Kubota Vision Inc.

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

Condition or disease Intervention/treatment
Macular Edema Macular Degeneration 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.

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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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
Group 1
Subjects with normal macular thickness in one or both eyes.
Device: RHMS-RTM
Assessment of retinal thickness.
Other Name: 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 Name: 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 Name: Handheld swept source (SS) optical coherence tomography (OCT)

Diagnostic Test: SD-OCT
Assessment of retinal structure.




Primary Outcome Measures :
  1. 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

  2. RHMS-RTM repeatability [ Time Frame: 1 day ]
    To assess repeatability of the RHMS-RTM device

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428242


Locations
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United States, California
Retinal Consultants Medical Group, Inc
Sacramento, California, United States, 95819
Sponsors and Collaborators
Kubota Vision Inc.
Investigators
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Study Director: Jeff Gregory, MD Kubota Vision Inc.
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Responsible Party: Kubota Vision Inc.
ClinicalTrials.gov Identifier: NCT04428242    
Other Study ID Numbers: SCT-202
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Kubota Vision Inc.:
Macular Edema, Wet AMD
Retinal Thickness
Diabetic Retinopathy, Retinal Vein Occlusion
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Edema
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases