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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Use of Avedro Inc. KXL 1 system to stop progression of keratoconus
Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex
Department of Ophhtalmology, University of Oslo
Oslo, Norway
RECRUITINGVisual acuity
Uncorrected and corrected distance visual acuity in logMAR
Time frame: 1 month after surgery
Risk of progression
Change in keratometric values
Time frame: 1 year after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Time frame: 3 month after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Time frame: 6 month after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Time frame: 1 year after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Time frame: 2 years after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Time frame: 5 years after surgery
Risk of progression
Change in keratometric values
Time frame: 1 month after surgery
Risk of progression
Change in keratometric values
Time frame: 3 months after surgery
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Risk of progression
Change in keratometric values
Time frame: 6 months after surgery
Risk of progression
Change in keratometric values
Time frame: 2 years after surgery
Risk of progression
Change in keratometric values
Time frame: 5 years after surgery
Depth of demarcation line (OCT)
Measured with corneal optical coherence tomography (OCT)
Time frame: 1 month after surgery
Depth of demarcation line (confocal microscopy)
Measured with confocal microscopy
Time frame: 1 month after surgery
Patient reported outcome measure (PROMs)
National eye institute Visual Function Questionnaire 25
Time frame: 1 month after surgery
Patient reported outcome measure (PROMs)
National eye institute Visual Function Questionnaire 25
Time frame: 6 months after surgery
Patient reported outcome measure (PROMs)
National eye institute Visual Function Questionnaire 25
Time frame: 2 years after surgery
Patient reported pain after surgery
Pain the first 48 hours after the surgery graded on visual analogue scale (VAS); 0 to 10 cm.
Time frame: 48 hours after surgery