Study Evaluating Retinal Health Monitoring System Thickness Module

Withdrawn before enrolling

Conditions studied: Macular Edema, Macular Degeneration

In brief

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

Key facts

Study ID

NCT04428242

Run by

Kubota Vision Inc.

People needed

0

Starts

2020-04-01

Expected to finish

2020-07-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Retinal Consultants Medical Group, Inc — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.