- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04428242
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Withdrawn
Conditions
Intervention / Treatment
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:
- Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
- Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to give informed consent
Group 1:
- Macula with normal thickness [central subfield thickness (CST) below 305 microns as measured by SD-OCT] in at least one eye
- Patients with dry AMD are eligible for enrollment into Group 1
- No history of wet AMD, DR, or RVO in either eye
Group 2 and Group 3 (in at least one or the same eye):
- History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
- Macular edema on SD-OCT with CST ≥ 305 microns
Exclusion Criteria:
- History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
- History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
- Participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening
- Refractive error: spherical equivalent of > 3 diopters of hyperopia or > 6 diopters of myopia, or > 2 diopters cylinder in the study eye(s)
- 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:
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:
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:
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCT-202
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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