Topical insulin for healing corneal epithelium after crosslinking in keratoconus patients
Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus: A Randomized Clinical Trial
PHASE3 · University of Campinas, Brazil · NCT06601101
This study is testing if insulin eye drops can help people with keratoconus heal better after a specific eye treatment called corneal crosslinking.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University of Campinas, Brazil (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Campinas, São Paulo) |
| Trial ID | NCT06601101 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of topical insulin on the healing of the corneal epithelium following corneal crosslinking in patients diagnosed with keratoconus. Participants will be randomly assigned to receive either insulin eye drops or a placebo, with the aim of assessing the impact on visual acuity and corneal health. The study will involve comprehensive evaluations including biomicroscopy, keratometry, and optical coherence tomography to monitor healing progress. The goal is to determine if insulin can enhance epithelial recovery and reduce postoperative complications.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with keratoconus who are indicated for corneal crosslinking.
Not a fit: Patients with diabetes mellitus, severe dry eye, limbal stem cell deficiency, glaucoma, or allergies to insulin or methylcellulose may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing times and reduce complications for patients undergoing corneal crosslinking.
How similar studies have performed: While the use of insulin in this context is novel, previous studies have explored growth factors for corneal healing, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of keratoconus, indicated for corneal crosslinking Exclusion Criteria: * Diabetes Mellitus * Severe dry eye * Limbal Stem Cell Deficiency * Glaucoma * Insulin or methylcellulose allergy
Where this trial is running
Campinas, São Paulo
- State University of Campinas — Campinas, São Paulo, Brazil (RECRUITING)
Study contacts
- Study coordinator: Vitor Guimarães, MD
- Email: vitorborgesguimaraes@gmail.com
- Phone: +55 64 99658-8797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratoconus, Cornea Disease, Eye Diseases, Wound Heal, Topical Insulin, Crosslinking