Evaluation of the Retinal Health Monitoring System Thickness Module

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499703
• Other study ID #: SCT-202 D
• Status: Completed
• Start date: November 11, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: February 2021
• Source: Kubota Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Edema
• Macular Degeneration
• Macular Edema

Intervention

Device:
• RHMS-RTM
Assessment of retinal thickness

Diagnostic Test:
• SD-OCT
Assessment of retinal structure

Locations

Country	Name	City	State
Switzerland	Inselspital, University Hospital Bern, Department of Ophthalmology	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Kubota Vision Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the RHMS-RTM retinal thickness measurements	To evaluate the ability of the RHMS-RTM device to measure retinal thickness	1 day
Secondary	Repeatability of RHMS-RTM retina thickness measurements	To assess repeatability of the RHMS-RTM device	1 day
Secondary	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
Secondary	Intraretinal and subretinal fluid detection	To evaluate the feasibility of intra- and sub-retinal fluid detection	1 day