+1 877 705 1914• 24 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 3
Age: 14Years +
All Genders
ID06601101

Study of Insulin Eye Drops to Help Healing After Corneal Crosslinking Surgery in Patients With Keratoconus

Led by University of Campinas, Brazil · Updated on 2025-01-14

36

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of insulin eye drops on healing the corneal epithelium in non-diabetic patients with keratoconus undergoing corneal crosslinking. Keratoconus weakens the cornea, and crosslinking is a surgical procedure to strengthen it by removing the corneal epithelium and applying riboflavin plus UV-A radiation. The study tests whether insulin eye drops can improve healing speed and reduce complications compared to placebo. Participants will be randomly assigned to one of two groups one receiving insulin eye drops at 50 IUml and the other receiving placebo drops containing 0.5% methylcellulose. Both groups will use their assigned drops four times daily until full epithelial healing. The crosslinking procedure involves removing the corneal epithelium using alcohol and a scraper, followed by riboflavin application and UV-A exposure. Standard postoperative care with antibiotics, steroids, lubricants, and silicone-hydrogel contact lenses will be given to all participants. Participants will attend follow-up visits on days 1, 2, 3, 6, and every 48 hours afterward until healing completes, typically within one week. Corneal healing will be documented with photographs and analyzed using specialized software. Additional assessments including biomicroscopy, tonometry, visual acuity, refraction, corneal tomography, and endothelial cell counts will occur up to 60 days after treatment. The primary outcome is the rate of corneal epithelial healing, with safety monitored throughout the study.

CONDITIONS

Brief Title

Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus

Research Team

V

Vitor Guimarães, MD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here