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
|Condition or disease||Intervention/treatment|
|Keratoconus||Procedure: corneal cross linking|
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.
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|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|
- Procedure: corneal cross linking
Iontophoretic corneal cross linking
- : 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)
- 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)
- 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.