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Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus

NCT ID: NCT01181219

Last Updated: 2014-12-12

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

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CXL without epithelial removal

Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium

Group Type EXPERIMENTAL

CXL without epithelial removal

Intervention Type PROCEDURE

UV-radiation of a Riboflavin saturated cornea without prior epithelial removal

CXL with epithelial removal

Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation

Group Type ACTIVE_COMPARATOR

CXL with epithelial removal

Intervention Type PROCEDURE

UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed

Interventions

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CXL without epithelial removal

UV-radiation of a Riboflavin saturated cornea without prior epithelial removal

Intervention Type PROCEDURE

CXL with epithelial removal

UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksandar Stojanovic, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital North Norway

Locations

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University Hospital North Norway

Tromsø, Troms, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 25050368 (View on PubMed)

Other Identifiers

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CXL-TE UNN2010

Identifier Type: -

Identifier Source: org_study_id