Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Study Overview
=================
Brief Summary
-----------------
Assess the performance and usability of the RHMS Visual Acuity Module.

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.

Official Title
-----------------
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)

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)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort 1 - Normal subjects Age ≥ 50 years Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye Able to perform self-testing with the Visual Acuity Module of the RHMS after training Able and willing to give informed consent Cohort 2 - 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 Exclusion Criteria: Cohort 1 - Normal subjects History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye 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 History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye History of macular hole in the study eye Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal subjects<br>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<br>* Assessment of corrected near visual acuity<br>Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)<br>* Assessment of corrected near visual acuity<br>|
| Subjects with neovascular AMD<br>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<br>* Assessment of corrected near visual acuity<br>Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)<br>* Assessment of corrected near visual acuity<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-Related Macular Degeneration, visual acuity