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

Bambino Gesù Hospital and Research Institute

Status: Completed

Conditions: Keratoconus

Treatments: Procedure: corneal cross-linking

Study type: Observational

Funder types: Other

Identifiers

NCT03753009

PCXL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

iontophoretic transepithelial corneal cross-linking (I-ON CXL)

Description:

Twenty eyes of 15 patients with keratoconus (mean age 13±3.5 \[SD\] years, range 9 to 18) underwent Iontophoresis epi-on CXL

Treatment:

Procedure: corneal cross-linking

epithelium-off collagen cross-linking (epi-off CXL)

Description:

Twenty eyes of 13 patients with keratoconus (14±4 \[SD\] years, range 10 to 18) underwent standard epi-off CXL

Treatment:

Procedure: corneal cross-linking