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

Completed

• Conditions: Keratoconus
• Interventions: Procedure: corneal cross-linking

• Registration Number: NCT03753009
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief 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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Last Update Submitted: 2018-11-22
• Study First Posted: 2018-11-26
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• clinical diagnosis of Keratoconus age < 18 years at the treatment; corneal cross linking performed at least 3 years before

Exclusion Criteria

• age > 18 years at the treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
epithelium-off collagen cross-linking (epi-off CXL)	corneal cross-linking	Twenty eyes of 13 patients with keratoconus (14±4 \[SD\] years, range 10 to 18) underwent standard epi-off CXL
iontophoretic transepithelial corneal cross-linking (I-ON CXL)	corneal cross-linking	Twenty eyes of 15 patients with keratoconus (mean age 13±3.5 \[SD\] years, range 9 to 18) underwent Iontophoresis epi-on CXL

Primary Outcome Measures

Name	Time	Method
keratoconus stability	3 years	To evaluate change of simulated maximum K (Kmax) that was calculated by a Sirius Scheimpflug camera (CSO, Firenze, Italy) by averaging the axial curvature from the fourth to the eighth Placido rings of the flattest and steepest meridians (the amplitude of the zone taken into consideration, therefore has a vari-able diameter depending on the curvature of the cornea, and the principal meridians are not nec-essarily 90 degrees away)