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Completed

NCT Number: NCT03661164

Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

corneal cross linking

Procedure

Iontophoretic corneal cross linking

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Luca Buzzonetti

Other

Registry information

Official study title

Factors Influencing Keratoconus Progression After Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients: Three Year Follow up

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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