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

University of Oslo (UIO)

Status: Enrolling

Conditions: Keratoconus

Treatments: Procedure: Corneal collagen cross linking (CXL); Procedure: Transepithelial phototherapeutic keratectomy (t-PTK)

Study type: Interventional

Funder types: Other

Identifiers

NCT06264024

519516

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

CXL

Active Comparator group

Description:

Treatment with CXL alone

Treatment:

Procedure: Corneal collagen cross linking (CXL)

CXL and t-PTK

Experimental group

Description:

Treatment with t-PTK combined with CXL

Treatment:

Procedure: Corneal collagen cross linking (CXL)

Procedure: Transepithelial phototherapeutic keratectomy (t-PTK)