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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06264024

Enrollment

Registered

2024-02-16

Start date

2024-02-12

Completion date

2034-02-01

Last updated

2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

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.

Interventions

PROCEDURECorneal collagen cross linking (CXL)

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

PROCEDURETransepithelial phototherapeutic keratectomy (t-PTK)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Depth of demarcation line (OCT)	1 month after surgery	Measured with corneal optical coherence tomography (OCT)
Depth of demarcation line (confocal microscopy)	1 month after surgery	Measured with confocal microscopy
Visual acuity	3 month after surgery	Uncorrected and corrected distance visual acuity in logMAR
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.
Patient reported outcome measure (PROMs)	1 month after surgery	National eye institute Visual Function Questionnaire 25
Risk of progression	1 month after surgery	Change in keratometric values

Countries

Norway

Contacts

Primary ContactOlav Kristianslund, MD, PhD

olakri@ous-hf.no+4722118545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026