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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04169802

Enrollment

Registered

2019-11-20

Start date

2019-11-20

Completion date

2020-04-15

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

Age-Related Macular Degeneration, visual acuity

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.

Interventions

DIAGNOSTIC_TESTRetinal Health Monitoring System Visual Acuity Module

Assessment of corrected near visual acuity

DIAGNOSTIC_TESTSloan letter, logarithmic near visual acuity chart (Reference Chart)

Assessment of corrected near visual acuity

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	1 day	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).
Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	1 day	To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart	1 day	To evaluate the usability of the RHMS Visual Acuity Module

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026