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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 hours of an office visit
Awards & highlights
Summary
Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites.
Eligible Conditions
- Diabetic Macular Edema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 hours of an office visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 hours of an office visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Compare fluid quantification in images from NVHO and a commercial OCT
Evaluate subjects' ability to perform multiple OCT self-scanning following a self-tutorial on the Notal Vision Home OCT (NVHO)
Evaluate the repeatability of the Notal OCT Analyzer (NOA) automatic fluid volume quantification in volume scan from self-scanning with the NVHO in the central 10 degrees of the macula of Diabetic Retinopathy (DR) patients
Secondary study objectives
Safety Endpoints
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Who is running the clinical trial?
Notal Vision Inc.Lead Sponsor
8 Previous Clinical Trials
20,644 Total Patients Enrolled
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