Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)

Not Applicable

Recruiting

• Conditions: Keratoconus
• Interventions: Procedure: Corneal collagen cross linking (CXL); Procedure: Transepithelial phototherapeutic keratectomy (t-PTK)

• Registration Number: NCT06264024
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study Start: 2024-02-12
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2025-05-01
• Study Completion: 2034-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CXL	Corneal collagen cross linking (CXL)	Treatment with CXL alone
CXL and t-PTK	Corneal collagen cross linking (CXL)	Treatment with t-PTK combined with CXL
CXL and t-PTK	Transepithelial phototherapeutic keratectomy (t-PTK)	Treatment with t-PTK combined with CXL

Primary Outcome Measures

Name	Time	Method
Risk of progression	1 year after surgery	Change in keratometric values
Visual acuity	1 month after surgery	Uncorrected and corrected distance visual acuity in logMAR

Secondary Outcome Measures

Name	Time	Method
Visual acuity	5 years after surgery	Uncorrected and corrected distance visual acuity in logMAR
Depth of demarcation line (confocal microscopy)	1 month after surgery	Measured with confocal microscopy
Patient reported outcome measure (PROMs)	2 years after surgery	National eye institute Visual Function Questionnaire 25
Risk of progression	5 years after surgery	Change in keratometric values
Depth of demarcation line (OCT)	1 month after surgery	Measured with corneal optical coherence tomography (OCT)
Patient reported pain after surgery	48 hours after surgery	Pain the first 48 hours after the surgery graded on visual analogue scale (VAS); 0 to 10 cm.

Trial Locations

Locations (1)

Department of Ophhtalmology, University of Oslo; 🇳🇴 Oslo, Norway