Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Age Related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169802
• Other study ID #: SCT-201
• Status: Completed
• Start date: November 20, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: February 2021
• Source: Kubota Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Diagnostic Test:
• Retinal Health Monitoring System Visual Acuity Module
Assessment of corrected near visual acuity
• Sloan letter, logarithmic near visual acuity chart (Reference Chart)
Assessment of corrected near visual acuity

Locations

Country	Name	City	State
United States	Retina Consultants of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kubota Vision Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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