Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients

NCT ID: NCT03661164

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-01

Study Completion Date

2015-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Keratoconus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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corneal cross linking

Iontophoretic corneal cross linking

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luca Buzzonetti

OTHER

Sponsor Role lead

Responsible Party

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Luca Buzzonetti

Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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ICXL

Identifier Type: -

Identifier Source: org_study_id

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