Evaluation of the Retinal Health Monitoring System Thickness Module

Completed

• Conditions: Macular Edema; Macular Degeneration
• Interventions: Device: RHMS-RTM; Diagnostic Test: SD-OCT

• Registration Number: NCT04499703
• Lead Sponsor: Kubota Vision Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Study Start: 2020-11-11
• Primary Completion: 2021-01-25
• Study Completion: 2021-01-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	SD-OCT	Subjects with normal macular thickness in one or both eyes.
Group 2	SD-OCT	Subjects with center-involving macular edema due to wAMD in one or both eyes
Group 3	SD-OCT	Subjects with center-involving macular edema due to DR or RVO in one or both eyes
Group 1	RHMS-RTM	Subjects with normal macular thickness in one or both eyes.
Group 2	RHMS-RTM	Subjects with center-involving macular edema due to wAMD in one or both eyes
Group 3	RHMS-RTM	Subjects with center-involving macular edema due to DR or RVO in one or both eyes

Primary Outcome Measures

Name	Time	Method
Evaluation of the RHMS-RTM retinal thickness measurements	1 day	To evaluate the ability of the RHMS-RTM device to measure retinal thickness

Secondary Outcome Measures

Name	Time	Method
Repeatability of RHMS-RTM retina thickness measurements	1 day	To assess repeatability of the RHMS-RTM device
Intraretinal and subretinal fluid detection	1 day	To evaluate the feasibility of intra- and sub-retinal fluid detection
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT	1 day	To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT

Trial Locations

Locations (1)

Inselspital, University Hospital Bern, Department of Ophthalmology; 🇨🇭 Bern, Switzerland