RECRUITINGINTERVENTIONAL
Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
About This Trial
The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK. The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patients must be 18 years or older at the time of signing the willing to sign a consent form form. There is no upper age limit.
- Progressive keratoconus with indication for CXL
- Corneal thickness ≥ 420 μm
Who Should NOT Join This Trial:
- Other eye disease causing visual impairment
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
* Progressive keratoconus with indication for CXL
* Corneal thickness ≥ 420 μm
Exclusion Criteria:
* Other eye disease causing visual impairment
Treatments Being Tested
PROCEDURE
Corneal collagen cross linking (CXL)
Use of Avedro Inc. KXL 1 system to stop progression of keratoconus
PROCEDURE
Transepithelial phototherapeutic keratectomy (t-PTK)
Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex
Locations (1)
Department of Ophhtalmology, University of Oslo
Oslo, Norway