Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module; Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)

• Registration Number: NCT04169802
• Lead Sponsor: Kubota Vision Inc.

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.

Study Timeline

• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-19
• Study Start: 2019-11-20
• Study First Posted: 2019-11-20
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with neovascular AMD	Retinal Health Monitoring System Visual Acuity Module	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.
Normal subjects	Retinal Health Monitoring System Visual Acuity Module	Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.
Subjects with neovascular AMD	Sloan letter, logarithmic near visual acuity chart (Reference Chart)	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.
Normal subjects	Sloan letter, logarithmic near visual acuity chart (Reference Chart)	Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.

Primary Outcome Measures

Name	Time	Method
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
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).

Trial Locations

Locations (1)

Retina Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States