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Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03661164
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Luca Buzzonetti, Bambino Gesù Hospital and Research Institute

Brief Summary:
To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression

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

Detailed Description:

Purpose: To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression.

Methods: Thirthyfive eyes of 22 consecutive pediatric patients (mean age 14.3±2.5 years) with keratoconus are evaluated in this retrospective study. Subgroup A and B are made up in function of progression in maximum K (Kmax,) defined as steepening of 1.0 diopter or more recorded three year after CXL. Corrected distance visual acuity (CDVA), spherical equivalent, topographic cone location, Kmax, posterior elevation of the thinnest point and thinnest point are evaluated. A paired Student t test is used to compare preoperative and 12, 24, and 36 month postoperative da-ta. A P value <0.05 was considered significant.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Influencing Keratoconus Progression After Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients: Three Year Follow up
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015



Intervention Details:
  • Procedure: corneal cross linking
    Iontophoretic corneal cross linking


Primary Outcome Measures :
  1. : Preoperative Kmax [ Time Frame: 3 years ]
    Simulated maximum K (Kmax) is 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)

  2. posterior elevation of the thinnest point [ Time Frame: 3 years ]
    posterior elevation of the thinnest point is measured by a Sirius Scheimpflug camera (CSO, Firenze, Italy)

  3. cone location [ Time Frame: 3 years ]
    The topographic cone location is assessed at the preoperative visit as follows : central for cor-neas having maximum K located within the central 3 mm and paracentral for corneas having maximum K located within the central 3 to 5 mm.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Thirtyfive eyes of 22 consecutive pediatric patients (5 female and 17 male; mean age 14.3±2.5 [SD] years; range, 9 to 18 years) affected by keratoconus (diagnosis established accord-ing to global consensus on keratoconus and ectatic diseases) who underwent transepithelial corneal cross-linking by iontophoresis are enrolled in this retrospective study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age > 18 years at the treatment

I

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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: NCT03661164    
Other Study ID Numbers: ICXL
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases