Actively Recruiting
Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus: A Randomized Clinical Trial
Led by University of Campinas, Brazil · Updated on 2025-01-14
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 IU/ml 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of keratoconus
- Indicated for corneal crosslinking
- Age 14 years or older
- Both genders
You will not qualify if you...
- Diabetes Mellitus
- Severe dry eye
- Limbal Stem Cell Deficiency
- Glaucoma
- Allergy to insulin or methylcellulose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are evaluated for keratoconus diagnosis and suitability for corneal crosslinking including visual acuity, refraction, biomicroscopy, and other eye assessments.
Duration - Up to 1 week or until complete corneal epithelial healing
Participants undergo corneal crosslinking followed by treatment with either insulin eye drops or placebo eye drops until complete corneal epithelial healing.
Postoperative visits on Days 1, 2, 3, 6 and every 48 hours thereafter until healing
Duration - Up to 60 days post-procedure
Participants continue postoperative eye care and undergo follow-up assessments to monitor eye health and healing progress.
Visits on Days 30 and 60 post-procedure
Trial Site Locations
Total: 1 location
1
State University of Campinas
Campinas, São Paulo, Brazil, 13.083-887
Actively Recruiting
Research Team
V
Vitor Guimarães, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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