NCT04169802

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

November 17, 2019

Last Update Submit

February 18, 2021

Conditions

Age Related Macular Degeneration

Keywords

Age-Related Macular Degenerationvisual acuity

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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

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

Interventions

Retinal Health Monitoring System Visual Acuity ModuleDIAGNOSTIC_TEST

Assessment of corrected near visual acuity

Normal subjectsSubjects with neovascular AMD
Sloan letter, logarithmic near visual acuity chart (Reference Chart)DIAGNOSTIC_TEST

Assessment of corrected near visual acuity

Normal subjectsSubjects with neovascular AMD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Consultants of Arizona

Phoenix, Arizona, 85053, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Jeff Gregory, MD

    Kubota Vision Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2019

First Posted

November 20, 2019

Study Start

November 20, 2019

Primary Completion

April 15, 2020

Study Completion

April 15, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(1)