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

NCT03753009 | Completed

• 1 other identifier: PCXL
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• keratoconus stability

  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)

  3 years

Study Arms (2)

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

Procedure: corneal cross-linking

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

Procedure: corneal cross-linking

Interventions

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

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Thirty eyes of 28 consecutive pediatric patients (7 female and 21 male; mean age 14.3±2.5 \[SD\] years; range, 9 to 18 years) affected by keratoconus (diagnosis established according to global consensus on keratoconus and ectatic diseases) who underwent iontophoresic transepithelial corneal cross-linking by or epithelium-off corneal cross-linking are enrolled in this retrospective study

You may qualify if:

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

You may not qualify if:

• age \> 18 years at the treatment

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Photochemotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Luca Buzzonetti, MD

  Bambino Gesù Children's Hospital, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 26, 2018
• Study Start: January 1, 2013
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share