An observational study in Keratoconus, sponsored by Luca Buzzonetti. Completed. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by Luca Buzzonetti · Observational
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
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.
312 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 22 is below the median of 130 across 96 observational studies indexed under Keratoconus.
Browse Keratoconus studies →Luca Buzzonetti is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
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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
Iontophoretic corneal cross linking
: Preoperative Kmax
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)
Time frame: 3 years
posterior elevation of the thinnest point
posterior elevation of the thinnest point is measured by a Sirius Scheimpflug camera (CSO, Firenze, Italy)
Time frame: 3 years
cone location
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.
Time frame: 3 years
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Luca Buzzonetti