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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04169802
Other study ID # SCT-201
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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