Study Evaluating Retinal Health Monitoring System Thickness Module

Kubota Vision

Status: Withdrawn

Conditions: Macular Degeneration; Macular Edema

Treatments: Diagnostic Test: SD-OCT; Device: RHMS-RTM

Study type: Observational

Funder types: Industry

Identifiers

NCT04428242

SCT-202

Details and patient eligibility

About

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

Full description

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

0 participants in 3 patient groups

Group 1

Description:

Subjects with normal macular thickness in one or both eyes.

Treatment:

Diagnostic Test: SD-OCT

Device: RHMS-RTM

Group 2

Description:

Subjects with center-involving macular edema due to w/AMD in one or both eyes.

Treatment:

Diagnostic Test: SD-OCT

Device: RHMS-RTM

Group 3

Description:

Subjects with center-involving macular edema due to DR or RVO in one or both eyes.

Treatment:

Diagnostic Test: SD-OCT

Device: RHMS-RTM