Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
Primary Purpose
Keratoconus
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
CXL without epithelial removal
CXL with epithelial removal
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- Documented keratoconus progression in both eyes during the last 12 months before the treatment - decrease in best spectacle-corrected visual acuity (BSCVA) and/or increase in cornea curvature or asymmetry
- Corneal thickness ≥400μm at the thinnest point
- Age range from 18 to 40
- Amsler-Krumeich classification graded stage I to III
Exclusion Criteria:
- Corneal thickness <400μm at the thinnest point
- History of viral keratitis
- Severe dry eye
- Concurrent corneal infections
- Previous ocular surgery
- Hard contact lens wear for ≤4 weeks before baseline examination
Sites / Locations
- University Hospital North Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CXL without epithelial removal
CXL with epithelial removal
Arm Description
Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium
Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation
Outcomes
Primary Outcome Measures
Best corrected distant visual acuity (BCDVA)
Secondary Outcome Measures
Corneal topographic keratoconus features
Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness).
Full Information
NCT ID
NCT01181219
First Posted
August 12, 2010
Last Updated
December 11, 2014
Sponsor
University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT01181219
Brief Title
Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
Official Title
Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Transepithelial CXL (performed without epithelial removal) seem to have similar clinical effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal). The current study attempts to prove that hypothesis.
A prospective, controlled, randomized, contralateral trial, will involve one eye of the patient to be treated with transepithelial CXL, while the control eye will be treated with the standard CXL. Totally 20 patients (age >18 and <40 years) referred by an ophthalmologist to the eye department of the University Hospital North Norway for CXL treatment of bilateral progressive keratoconus, will be recruited.
Detailed Description
CXL appears to hinder the development of keratoconus by strengthening the cross-bindings in the corneal stroma with a resultant increase in corneal biomechanical strength of up to 300%. The method was introduced in the mid-nineties and has been approved for use in the EU countries since 2007. Standard treatment protocol, involving the removal of the corneal epithelium before the Riboflavin application, has been used. In order to avoid potential complications following removal of the epithelium (infection, delayed healing, scar formation, as well as discomfort and pain), a modified procedure where the epithelium is kept intact, so called transepithelial CXL, has been suggested. According to the preliminary results of the published retrospective studies, no significant difference in the clinical effect between the standard CXL with epithelial removal and the transepithelial CXL was found.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CXL without epithelial removal
Arm Type
Experimental
Arm Description
Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium
Arm Title
CXL with epithelial removal
Arm Type
Active Comparator
Arm Description
Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation
Intervention Type
Procedure
Intervention Name(s)
CXL without epithelial removal
Intervention Description
UV-radiation of a Riboflavin saturated cornea without prior epithelial removal
Intervention Type
Procedure
Intervention Name(s)
CXL with epithelial removal
Intervention Description
UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed
Primary Outcome Measure Information:
Title
Best corrected distant visual acuity (BCDVA)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Corneal topographic keratoconus features
Description
Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness).
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented keratoconus progression in both eyes during the last 12 months before the treatment - decrease in best spectacle-corrected visual acuity (BSCVA) and/or increase in cornea curvature or asymmetry
Corneal thickness ≥400μm at the thinnest point
Age range from 18 to 40
Amsler-Krumeich classification graded stage I to III
Exclusion Criteria:
Corneal thickness <400μm at the thinnest point
History of viral keratitis
Severe dry eye
Concurrent corneal infections
Previous ocular surgery
Hard contact lens wear for ≤4 weeks before baseline examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar Stojanovic, MD
Organizational Affiliation
University Hospital North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital North Norway
City
Tromsoe
State/Province
Troms
ZIP/Postal Code
9000
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25050368
Citation
Stojanovic A, Zhou W, Utheim TP. Corneal collagen cross-linking with and without epithelial removal: a contralateral study with 0.5% hypotonic riboflavin solution. Biomed Res Int. 2014;2014:619398. doi: 10.1155/2014/619398. Epub 2014 Jun 22.
Results Reference
derived
Learn more about this trial
Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
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