Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
1 other identifier
interventional
81
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2024
CompletedStudy Start
First participant enrolled
February 12, 2024
CompletedFirst Posted
Study publicly available on registry
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2034
ExpectedFebruary 16, 2024
February 1, 2024
1.2 years
January 29, 2024
February 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
1 month after surgery
Risk of progression
Change in keratometric values
1 year after surgery
Secondary Outcomes (16)
Visual acuity
3 month after surgery
Visual acuity
6 month after surgery
Visual acuity
1 year after surgery
Visual acuity
2 years after surgery
Visual acuity
5 years after surgery
- +11 more secondary outcomes
Study Arms (2)
CXL
ACTIVE COMPARATORTreatment with CXL alone
CXL and t-PTK
EXPERIMENTALTreatment with t-PTK combined with CXL
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other eye disease causing visual impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophhtalmology, University of Oslo
Oslo, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 29, 2024
First Posted
February 16, 2024
Study Start
February 12, 2024
Primary Completion
May 1, 2025
Study Completion (Estimated)
February 1, 2034
Last Updated
February 16, 2024
Record last verified: 2024-02