Evaluation of the Retinal Health Monitoring System Thickness Module

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema

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

Study Overview

• Status: Completed
• Conditions: Macular Degeneration; Macular Edema
• Intervention / Treatment: Device: RHMS-RTM; Diagnostic test: SD-OCT

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, University Hospital Bern, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged ≥ 50 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Subjects with normal macular thickness in one or both eyes.	Device: RHMS-RTM; Assessment of retinal thickness; Other Names: Handheld swept source (SS) optical coherence tomography (OCT); Diagnostic test: SD-OCT; Assessment of retinal structure
Group 2; Subjects with center-involving macular edema due to wAMD in one or both eyes	Device: RHMS-RTM; Assessment of retinal thickness; Other Names: Handheld swept source (SS) optical coherence tomography (OCT); Diagnostic test: SD-OCT; Assessment of retinal structure
Group 3; Subjects with center-involving macular edema due to DR or RVO in one or both eyes	Device: RHMS-RTM; Assessment of retinal thickness; Other Names: Handheld swept source (SS) optical coherence tomography (OCT); Diagnostic test: SD-OCT; Assessment of retinal structure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the RHMS-RTM retinal thickness measurements	To evaluate the ability of the RHMS-RTM device to measure retinal thickness	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.
• Investigators: Principal Investigator: Marion Munk, MD, PhD, Inselspital, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: diabetic macular edema; macular edema; Age-Related Macular Degeneration; retinal vein occlusion
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: SCT-202 D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No