Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)

Assess the performance and usability of the RHMS Visual Acuity Module.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Diagnostic test: Retinal Health Monitoring System Visual Acuity Module; Diagnostic test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)

Detailed Description

This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Retina Consultants of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD

Description

Inclusion Criteria:

Cohort 1 - Normal subjects

1. Age ≥ 50 years
2. Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye
3. Able to perform self-testing with the Visual Acuity Module of the RHMS after training
4. Able and willing to give informed consent

Cohort 2 - Subjects with neovascular AMD

1. Age ≥ 50 years
2. History of neovascular age-related macular degeneration, in the study eye
3. Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye

Exclusion Criteria:

Cohort 1 - Normal subjects

1. History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye
2. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Cohort 2 - Subjects with neovascular AMD

1. History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye
2. History of macular hole in the study eye
3. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal subjects; Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.	Diagnostic test: Retinal Health Monitoring System Visual Acuity Module; Assessment of corrected near visual acuity; Diagnostic test: Sloan letter, logarithmic near visual acuity chart (Reference Chart); Assessment of corrected near visual acuity
Subjects with neovascular AMD; Age ≥ 50 years, History of neovascular age-related macular degeneration, in the study eye, Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye.	Diagnostic test: Retinal Health Monitoring System Visual Acuity Module; Assessment of corrected near visual acuity; Diagnostic test: Sloan letter, logarithmic near visual acuity chart (Reference Chart); Assessment of corrected near visual acuity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	To determine the precision (repeatability and reproducibility) of corrected near visual acuity (CNVA) measured by the RHMS Visual Acuity Module and an in-clinic, near logarithmic Sloan Letter chart (Reference Chart).	1 day
Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	1 day
Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	To evaluate the usability of the RHMS Visual Acuity Module	1 day

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): April 15, 2020
• Study Completion (ACTUAL): April 15, 2020

Study Registration Dates

• First Submitted: November 17, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Age-Related Macular Degeneration; visual acuity
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: SCT-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes