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

NCT ID: NCT06264024

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2034-02-01

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.

Conditions

Keratoconus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CXL

Treatment with CXL alone

Group Type: ACTIVE_COMPARATOR

Corneal collagen cross linking (CXL)

Intervention Type: PROCEDURE

Use of Avedro Inc. KXL 1 system to stop progression of keratoconus

CXL and t-PTK

Treatment with t-PTK combined with CXL

Group Type: EXPERIMENTAL

Corneal collagen cross linking (CXL)

Intervention Type: PROCEDURE

Use of Avedro Inc. KXL 1 system to stop progression of keratoconus

Transepithelial phototherapeutic keratectomy (t-PTK)

Intervention Type: PROCEDURE

Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex

Interventions

Corneal collagen cross linking (CXL)

Use of Avedro Inc. KXL 1 system to stop progression of keratoconus

Intervention Type: PROCEDURE

Transepithelial phototherapeutic keratectomy (t-PTK)

Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olav Kristianslund

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Ophhtalmology, University of Oslo

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Olav Kristianslund, MD, PhD

Role: CONTACT

olakri@ous-hf.no

+4722118545

Facility Contacts

Olav Kristianslund, MD, PhD

Role: primary

olakri@ous-hf.no

Bjarne L Thorbjørnsen, MD

Role: backup

uxtbja@ous-hf.no

Other Identifiers

519516

Identifier Type: -

Identifier Source: org_study_id