NCT03753009

Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: —

Summary

To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.

Detailed description

Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 \[SD\] years; range, 9 to 18 years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest point and thickness of the thinnest point mean values were evaluated. A Student t test was used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression in function of preoperative Kmax value and cone location was evaluated at 36 months.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	corneal cross-linking	Epithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2. The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-06-30
• Completion: 2015-06-30
• First posted: 2018-11-26
• Last updated: 2018-11-26