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Corneal Inlay
Raindrop for Presbyopia
Phase 3
Waitlist Available
Research Sponsored by ReVision Optics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision.
Eligible Conditions
- Presbyopia
- Pseudophakia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in uncorrected near visual acuity
Preservation of best corrected visual acuity
Secondary outcome measures
Adverse Events
Improvement in uncorrected intermediate visual acuity
Trial Design
1Treatment groups
Experimental Treatment
Group I: RaindropExperimental Treatment1 Intervention
A single arm study to evaluate the effectiveness of a 2mm Raindrop Near Vision Inlay for the treatment of presbyopia in pseudophakic subjects. This corneal inlay is placed under a LASIK flap or in a corneal pocket, and is designed to change the anterior curvature of the cornea, resulting in the ability to reduce spectacle dependency for near and intermediate tasks.
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Who is running the clinical trial?
ReVision Optics, Inc.Lead Sponsor
2 Previous Clinical Trials
386 Total Patients Enrolled
2 Trials studying Presbyopia
386 Patients Enrolled for Presbyopia
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