Evaluation of the Retinal Health Monitoring System Thickness Module

NCT04499703 | Completed

• 1 other identifier: SCT-202 D
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Macular Edema; Macular Degeneration

Keywords

Age-Related Macular Degeneration; macular edema; retinal vein occlusion; diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• Evaluation of the RHMS-RTM retinal thickness measurements

  To evaluate the ability of the RHMS-RTM device to measure retinal thickness

  1 day

Secondary Outcomes (3)

• Repeatability of RHMS-RTM retina thickness measurements

  1 day

• Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT

  1 day

• Intraretinal and subretinal fluid detection

  1 day

Study Arms (3)

Group 1

Subjects with normal macular thickness in one or both eyes.

Device: RHMS-RTM; Diagnostic Test: SD-OCT

Group 2

Subjects with center-involving macular edema due to wAMD in one or both eyes

Device: RHMS-RTM; Diagnostic Test: SD-OCT

Group 3

Subjects with center-involving macular edema due to DR or RVO in one or both eyes

Device: RHMS-RTM; Diagnostic Test: SD-OCT

Interventions

RHMS-RTM DEVICE

Assessment of retinal thickness

Also known as: Handheld swept source (SS) optical coherence tomography (OCT)

Group 1; Group 2; Group 3

SD-OCT DIAGNOSTIC_TEST

Assessment of retinal structure

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥50.
• Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
• Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
• Able to perform self-testing of retinal thickness with the RHMS-RTM after training
• Able and willing to provide written informed consent before undergoing any study-related procedures
• 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
• 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.

You may not qualify if:

• History of corneal refractive surgery \[e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)\] in the study eye(s)
• History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
• Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening
• Refractive error within defined limits
• History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)

Sponsors & Collaborators

• Kubota Vision Inc.: lead

Study Sites (1)

Inselspital, University Hospital Bern, Department of Ophthalmology

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Macular Edema; Macular Degeneration; Retinal Vein Occlusion

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Marion Munk, MD, PhD

  Inselspital, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: November 11, 2020
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CH (1)