Study Evaluating Retinal Health Monitoring System Thickness Module (NCT04428242) | Clinical Trial Compass
WithdrawnNot Applicable
Study Evaluating Retinal Health Monitoring System Thickness Module
Stopped: COVD-19
United States0Started 2020-04
Plain-language summary
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the RHMS-RTM retinal thickness measurements
Timeframe: 1 day
2
RHMS-RTM repeatability
Timeframe: 1 day
3
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT