Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients
Factors Influencing Keratoconus Progression After Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients: Three Year Follow up
1 other identifier
observational
22
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2013
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedSeptember 11, 2018
September 1, 2018
2.2 years
September 5, 2018
September 8, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
: 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)
3 years
posterior elevation of the thinnest point
posterior elevation of the thinnest point is measured by a Sirius Scheimpflug camera (CSO, Firenze, Italy)
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.
3 years
Interventions
Iontophoretic corneal cross linking
Eligibility Criteria
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.
You may qualify if:
- clinical diagnosis of Keratoconus age \< 18 years at the treatment iontophoretic corneal cross linking performed at least 3 years before
You may not qualify if:
- age \> 18 years at the treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luca Buzzonettilead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 7, 2018
Study Start
May 1, 2013
Primary Completion
June 30, 2015
Study Completion
June 30, 2015
Last Updated
September 11, 2018
Record last verified: 2018-09