Study Evaluating Retinal Health Monitoring System Visual Acuity Module.
NCT ID: NCT04169802
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
25 participants
OBSERVATIONAL
2019-11-20
2020-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Normal subjects
Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
ALL
Yes
Sponsors
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Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Gregory, MD
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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Retina Consultants of Arizona
Phoenix, Arizona, United States
Countries
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Other Identifiers
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SCT-201
Identifier Type: -
Identifier Source: org_study_id
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