Evaluation of the Retinal Health Monitoring System Thickness Module

Kubota Vision

Status: Completed

Conditions: Macular Degeneration; Macular Edema

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04499703

SCT-202 D

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.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥50.
2. Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
3. Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
4. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
5. Able and willing to provide written informed consent before undergoing any study-related procedures
6. Group 1: Macula with normal thickness [central subfield thickness (CST): <305μm in women, and <320μm in men as measured by Heidelberg Spectralis SD-OCT in at least one eye. Patients diagnosed with dry AMD are eligible for enrollment into Group 1. No history of wAMD, DR, or RVO in either eye
7. Group 2 and Group 3, in at least one and the same eye: History of center-involving macular edema due to wAMD (Group 2); or DR or RVO (Group 3); Macular edema on SD-OCT with CST ≥305 μm in women, and ≥320μm in men as measured by Heidelberg Spectralis SD-OCT.

Exclusion criteria

1. History of corneal refractive surgery [e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)] in the study eye(s)
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 of screening or an investigational device within 60 days of screening
4. Refractive error within defined limits
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

60 participants in 3 patient groups

Group 1

Description:

Subjects with normal macular thickness in one or both eyes.

Treatment:

Device: RHMS-RTM

Diagnostic Test: SD-OCT

Group 2

Description:

Subjects with center-involving macular edema due to wAMD in one or both eyes

Treatment:

Device: RHMS-RTM

Diagnostic Test: SD-OCT

Group 3

Description:

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

Treatment:

Device: RHMS-RTM

Diagnostic Test: SD-OCT