Study Evaluating 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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04428242
• Other study ID #: SCT-202
• Status: Withdrawn
• Start date: April 2020
• Est. completion date: July 2020

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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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
United States	Retinal Consultants Medical Group, Inc	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Kubota Vision Inc.

Country where clinical trial is conducted

United States, 

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
Primary	RHMS-RTM repeatability	To assess repeatability of the RHMS-RTM device	1 day
Primary	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 month