Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (COVD-19)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.

Tracking Information
First Submitted Date June 9, 2020
First Posted Date June 11, 2020
Last Update Posted Date June 11, 2020
Estimated Study Start Date April 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2020)
  • 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
  • RHMS-RTM repeatability [ Time Frame: 1 day ]
    To assess repeatability of the RHMS-RTM device
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating Retinal Health Monitoring System Thickness Module
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
Brief Summary Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Macular Edema
  • Macular Degeneration
Intervention
  • 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.
Study Groups/Cohorts
  • Group 1
    Subjects with normal macular thickness in one or both eyes.
    Interventions:
    • Device: RHMS-RTM
    • Diagnostic Test: SD-OCT
  • Group 2
    Subjects with center-involving macular edema due to w/AMD in one or both eyes.
    Interventions:
    • Device: RHMS-RTM
    • Diagnostic Test: SD-OCT
  • Group 3
    Subjects with center-involving macular edema due to DR or RVO in one or both eyes.
    Interventions:
    • Device: RHMS-RTM
    • Diagnostic Test: SD-OCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: June 9, 2020)
0
Original Actual Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04428242
Other Study ID Numbers SCT-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Kubota Vision Inc.
Study Sponsor Kubota Vision Inc.
Collaborators Not Provided
Investigators
Study Director: Jeff Gregory, MD Kubota Vision Inc.
PRS Account Kubota Vision Inc.
Verification Date June 2020