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

• ClinicalTrials.gov Identifier: NCT03753009
• Recruitment Status: Completed
• First Posted: November 26, 2018
• Last Update Posted: November 26, 2018
• Sponsor: Bambino Gesù Hospital and Research Institute
• Information provided by (Responsible Party): Luca Buzzonetti, Bambino Gesù Hospital and Research Institute

Study Description

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.

Condition or disease	Intervention/treatment
Keratoconus	Procedure: corneal cross-linking

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 Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.
• Actual Study Start Date: January 1, 2013
• Actual Primary Completion Date: June 30, 2015
• Actual Study Completion Date: June 30, 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
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 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	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.

Outcome Measures

Primary Outcome Measures :

1. keratoconus stability [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

Contacts and Locations

Sponsors and Collaborators

Bambino Gesù Hospital and Research Institute

Investigators

• Principal Investigator: Luca Buzzonetti, MD; Bambino Gesù Children's Hospital, Rome, Italy

More Information

• Responsible Party: Luca Buzzonetti, Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy, Bambino Gesù Hospital and Research Institute
• ClinicalTrials.gov Identifier: NCT03753009
• Other Study ID Numbers: PCXL
• First Posted: November 26, 2018
• Last Update Posted: November 26, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Keratoconus; Corneal Diseases; Eye Diseases