Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Completed

Conditions studied: Age Related Macular Degeneration

In brief

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

Key facts

Study ID

NCT04169802

Run by

Kubota Vision Inc.

People needed

25

Starts

2019-11-20

Expected to finish

2020-04-15

Last updated by the study team

2021-02-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Retina Consultants of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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