Keratoconus Clinical Trial
Official title:
Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
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.
Status | Recruiting |
Enrollment | 81 |
Est. completion date | February 1, 2034 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Ophhtalmology, University of Oslo | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 1 month after surgery | |
Primary | Risk of progression | Change in keratometric values | 1 year after surgery | |
Secondary | Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 3 month after surgery | |
Secondary | Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 6 month after surgery | |
Secondary | Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 1 year after surgery | |
Secondary | Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 2 years after surgery | |
Secondary | Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 5 years after surgery | |
Secondary | Risk of progression | Change in keratometric values | 1 month after surgery | |
Secondary | Risk of progression | Change in keratometric values | 3 months after surgery | |
Secondary | Risk of progression | Change in keratometric values | 6 months after surgery | |
Secondary | Risk of progression | Change in keratometric values | 2 years after surgery | |
Secondary | Risk of progression | Change in keratometric values | 5 years after surgery | |
Secondary | Depth of demarcation line (OCT) | Measured with corneal optical coherence tomography (OCT) | 1 month after surgery | |
Secondary | Depth of demarcation line (confocal microscopy) | Measured with confocal microscopy | 1 month after surgery | |
Secondary | Patient reported outcome measure (PROMs) | National eye institute Visual Function Questionnaire 25 | 1 month after surgery | |
Secondary | Patient reported outcome measure (PROMs) | National eye institute Visual Function Questionnaire 25 | 6 months after surgery | |
Secondary | Patient reported outcome measure (PROMs) | National eye institute Visual Function Questionnaire 25 | 2 years after surgery | |
Secondary | Patient reported pain after surgery | Pain the first 48 hours after the surgery graded on visual analogue scale (VAS); 0 to 10 cm. | 48 hours after surgery |
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