Actively Recruiting

Phase 3
Age: 14Years +
All Genders
ID06601101

Effects of Topical Insulin on 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

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess the effect of insulin eye drops on healing the corneal epithelium in non-diabetic patients undergoing corneal crosslinking for keratoconus. Corneal crosslinking is a surgical procedure that strengthens the cornea to prevent disease progression, but it requires removal of the corneal epithelium, which can cause pain and increase risks like infection and scarring. The study explores whether topical insulin can improve healing by promoting epithelial repair. Participants diagnosed with keratoconus and scheduled for crosslinking will be randomly assigned to one of two groups. One group will receive insulin eye drops at 50 IU/ml concentration, and the other will receive placebo drops containing 0.5% methylcellulose. Both groups will use their assigned drops four times a day until their corneal epithelium fully heals. Standard postoperative treatments including antibiotics, steroids, eye lubricants, and silicone-hydrogel contact lenses will be given to all participants. The study involves regular follow-up visits on days 1, 2, 3, 6, and thereafter every 48 hours until healing is complete, with additional visits on days 30 and 60. Researchers will monitor corneal healing using specialized photography, assess ocular health, measure epithelial defect size, and evaluate overall eye condition. The primary outcome is the rate of corneal epithelial healing over seven days. Participants and evaluators will be masked to treatment allocation to ensure unbiased results.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a diagnosis of keratoconus, indicated for corneal crosslinking
Not Eligible

You will not qualify if you...

  • Diabetes Mellitus
  • Severe dry eye
  • Limbal Stem Cell Deficiency
  • Glaucoma
  • Insulin or methylcellulose allergy

AI-Screening

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Trial Site Locations

Total: 1 location

1

State University of Campinas

Campinas, São Paulo, Brazil, 13.083-887

Actively Recruiting

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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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