Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Kubota Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Treatments: Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart); Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module

Study type: Observational

Funder types: Industry

Identifiers

NCT04169802

SCT-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

25 participants in 2 patient groups

Normal subjects

Description:

Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.

Treatment:

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

Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module

Subjects with neovascular AMD

Description:

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.

Treatment:

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

Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module