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A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C

Presbyopia Clinical Trial

Official title:
A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Treated With Mitomycin C During Surgery and Extended Steroid After Surgery

Clinical Trial 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.

Clinical Trial Description

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 corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket. In the third month after surgical procedure, one-drop a day of low dose steroid will be continued for the duration of the 24-month follow-up period to maintain corneal health. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03242317
Study type Interventional
Source Fichte, Endl & Elmer Eyecare
Contact Michael J Endl, MD
Phone (716) 564-2020
Email mpderme@aol.com
Status Recruiting
Phase Phase 4
Start date June 16, 2017
Completion date December 1, 2020
View Details
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