Clinical trial NCT04499703: Evaluation of the Retinal Health Monitoring System Thickness Module
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Macular Degeneration
Keywords: Age-Related Macular Degeneration
macular edema
retinal vein occlusion
diabetic macular edema
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of the RHMS-RTM retinal thickness measurements
timeFrame: 1 day
Secondary outcomes:
measure: Repeatability of RHMS-RTM retina thickness measurements
timeFrame: 1 day
measure: Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
timeFrame: 1 day
measure: Intraretinal and subretinal fluid detection
timeFrame: 1 day
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, Department of Ophthalmology
Study officials:
affiliation: Inselspital, University Hospital Bern
name: Marion Munk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: