Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
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ClinicalTrials.gov Identifier: NCT01181219 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : December 12, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconus | Procedure: CXL without epithelial removal Procedure: CXL with epithelial removal | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: CXL without epithelial removal
Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium
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Procedure: CXL without epithelial removal
UV-radiation of a Riboflavin saturated cornea without prior epithelial removal |
Active Comparator: CXL with epithelial removal
Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation
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Procedure: CXL with epithelial removal
UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed |
- Best corrected distant visual acuity (BCDVA) [ Time Frame: One year ]
- Corneal topographic keratoconus features [ Time Frame: One year ]Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness).

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181219
Norway | |
University Hospital North Norway | |
Tromsoe, Troms, Norway, 9000 |
Principal Investigator: | Aleksandar Stojanovic, MD | University Hospital North Norway |
Responsible Party: | University Hospital of North Norway |
ClinicalTrials.gov Identifier: | NCT01181219 |
Other Study ID Numbers: |
CXL-TE UNN2010 |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | December 12, 2014 |
Last Verified: | May 2012 |
Keratoconus Corneal Diseases Eye Diseases |