Clinical trial NCT04428242: Study Evaluating 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Overall status: WITHDRAWN
Conditions: Macular Edema
Macular Degeneration
Keywords: Macular Edema, Wet AMD
Retinal Thickness
Diabetic Retinopathy, Retinal Vein Occlusion
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged ≥ 18 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. 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)

Primary outcomes:
measure: Evaluation of the RHMS-RTM retinal thickness measurements
timeFrame: 1 day
measure: RHMS-RTM repeatability
timeFrame: 1 day
measure: Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc
state: California
Study officials:
affiliation: Kubota Vision Inc.
name: Jeff Gregory, MD
role: STUDY_DIRECTOR
References: