Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Sponsor

Kubota Vision Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04169802

Collaborator

(none)

Enrollment

Location

4.8

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)

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 Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

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)

Actual Study Start Date :

Nov 20, 2019

Actual Primary Completion Date :

Apr 15, 2020

Actual Study Completion Date :

Apr 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Normal subjects Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.	Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module Assessment of corrected near visual acuity Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart) Assessment of corrected near visual acuity
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.	Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module Assessment of corrected near visual acuity Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart) Assessment of corrected near visual acuity

Arm

Intervention/Treatment

Normal subjects

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

Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module

Assessment of corrected near visual acuity

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

Assessment of corrected near visual acuity

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.

Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module

Assessment of corrected near visual acuity

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

Assessment of corrected near visual acuity

Outcome Measures

Primary Outcome Measures

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).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Consultants of Arizona	Phoenix	Arizona	United States	85053

Sponsors and Collaborators

Kubota Vision Inc.

Investigators

Study Director: Jeff Gregory, MD, Kubota Vision Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kubota Vision Inc.

ClinicalTrials.gov Identifier:

NCT04169802

Other Study ID Numbers:

SCT-201

First Posted:

Nov 20, 2019

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Kubota Vision Inc.

Age-Related Macular Degeneration

visual acuity

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Feb 21, 2021