Study Evaluating Retinal Health Monitoring System Thickness Module

Withdrawn

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

• Registration Number: NCT04428242
• 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 Start: 2020-04
• Primary Completion: 2020-06
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Completion: 2020-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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 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 w/AMD 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.
Group 2	RHMS-RTM	Subjects with center-involving macular edema due to w/AMD 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
RHMS-RTM repeatability	1 day	To assess repeatability of the RHMS-RTM device
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT	1 month	To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT

Trial Locations

Locations (1)

Retinal Consultants Medical Group, Inc; 🇺🇸 Sacramento, California, United States