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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264024
• Other study ID #: 519516
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: February 1, 2034

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: Olav Kristianslund, MD, PhD
• Phone: +4722118545
• Email: olakri[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Corneal collagen cross linking (CXL)
Use of Avedro Inc. KXL 1 system to stop progression of keratoconus
• Transepithelial phototherapeutic keratectomy (t-PTK)
Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex

Locations

Country	Name	City	State
Norway	Department of Ophhtalmology, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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