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

NCT ID: NCT03753009

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2015-06-30

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.

Conditions

Keratoconus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

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

corneal cross-linking

Intervention Type: PROCEDURE

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.

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

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

corneal cross-linking

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Luca Buzzonetti

Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Buzzonetti, MD

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Children's Hospital, Rome, Italy

Other Identifiers

PCXL

Identifier Type: -

Identifier Source: org_study_id