Study Evaluating Retinal Health Monitor… | Clinical Trial

Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Consultants of Arizona

Phoenix, Arizona, 85053, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retinal Health Monitoring System Visual Acuity Module

Diagnostic Test

Assessment of corrected near visual acuity

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

Diagnostic Test

Assessment of corrected near visual acuity

Primary outcomes

Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart

Time frame: 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

Time frame: 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

Time frame: 1 day

To evaluate the usability of the RHMS Visual Acuity Module

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 20, 2019
Registry last updated: Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed