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Antineoplastic Agent
Mitomycin C + Raindrop Near Vision Inlay for Presbyopia
Phase 4
Waitlist Available
Led By Michael J Endl, MD
Research Sponsored by Fichte, Endl & Elmer Eyecare
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 Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes treated with low dose, short duration Mitomycin C (MMC) during surgery and an extended low dose steroid regimen after surgery.
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
Uncorrected Visual Acuity
Secondary outcome measures
Incidence of Corneal Reaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mitomycin C + Raindrop Near Vision InlayExperimental Treatment2 Interventions
The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the Raindrop Near Vision Inlay in Presbyopes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitomycin
FDA approved
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Who is running the clinical trial?
Fichte, Endl & Elmer EyecareLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Michael J Endl, MDPrincipal InvestigatorFichte, Endl & Elmer Eyecare
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