Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus
A legfontosabb adatok
- Ki végzi
- University of Campinas, Brazil
- Hol
- Brazília1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Leállítva
- Fázis
- 3. fázis
- Résztvevők
- 19 fő vett részt
- Kezdés
- 2024. aug. 1.
- Befejezés
- 2026. márc. 20.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- NPH insulin 50 IU/mL eye drops
- 0.5% methylcellulose eye drops (placebo)
- A regiszteradat frissítve
- 2026. november 5.
- Miért állt le
- Enrollment closed before the planned 36 eyes were reached because of the limited number of eligible patients and the long recruitment period (July 2024 to December 2025); 20 eyes of 19 participants were enrolled.
Ki vehet részt
- Életkor
- 14 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- Age 14 years or older
- Diagnosis of keratoconus with an indication for corneal crosslinking
Ki nem vehet részt
- Diabetes mellitus
- Dry eye disease
- Allergy to insulin or methylcellulose
- Limbal stem cell deficiency
- Glaucoma
- Irregular epithelial debridement and/or debridement other than 8.0 mm during the crosslinking procedure
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
The cornea plays a fundamental role in vision, being a complex tissue essential for ocular health. In ophthalmological practice, there are situations such as corneal crosslinking, where damage to the corneal epithelium occurs. Crosslinking is a surgical procedure aimed at strengthening collagen bonds in the corneal stroma to prevent the progression of keratoconus, through the application of topical riboflavin followed by ultraviolet (UV-A) radiation. To enhance the effectiveness of riboflavin and UV-A radiation, the corneal epithelium needs to be removed, which can cause postoperative pain and discomfort, as well as increase the risk of complications such as infections, scarring, corneal opacities, perforations, and recurrent epithelial erosions. Several growth factors play a role in epithelial healing, and the discovery of insulin in the tear film and the presence of insulin and Insulin-Like Growth Factor (IGF-1) receptors in the cornea has raised the hypothesis that insulin may modulate the cornea's wound healing response. Since then, topical insulin has been used for various ocular pathologies, including dry eye disease, persistent epithelial defects, and neurotrophic ulcers. Based on this knowledge, studies have been developed, and promising results regarding the use of insulin in corneal healing have been reported, providing a scientific foundation for the realization of this project.
A teljes eredeti leírásKevesebb
The objective of this study was to evaluate the effect of insulin eye drops at a concentration of 50 IU/ml on epithelial healing in non-diabetic patients undergoing epithelial debridement for corneal crosslinking. To this end, a randomized, double-masked clinical trial was conducted with two groups, one being the control group, in which researchers compared the epithelial healing rate in mm²/h between the insulin group and the placebo group, as the primary outcome. Patients diagnosed with keratoconus and with an indication for the crosslinking procedure were invited to participate.
The study was designed to assess and quantify the impact of topical insulin on epithelial defect closure in patients undergoing crosslinking, compared to placebo.
A vizsgálat 2 csoportja
- InsulinA vizsgált kezelés
NPH insulin 50 IU/mL eye drops (Eye Pharma, São Paulo, SP, Brazil), one drop four times daily until complete corneal epithelialization, added to the standard postoperative regimen.
Kezelés: NPH insulin 50 IU/mL eye drops
- PlaceboPlacebo, összehasonlításként
0.5% methylcellulose eye drops (Eye Pharma, São Paulo, SP, Brazil), the vehicle of the insulin formulation, one drop four times daily until complete corneal epithelialization, added to the standard postoperative regimen.
Kezelés: 0.5% methylcellulose eye drops (placebo)
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus: A Randomized Clinical Trial
- A regiszteradat frissítve
- 2026. november 5.