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Recruiting NCT06264024

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

No phase Interventional Keratoconus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Corneal collagen cross linking (CXL), Transepithelial phototherapeutic keratectomy (t-PTK).
Who it may be relevant to
Registry conditions: Keratoconus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Visual acuity [Time frame: 1 month after surgery]
  • Risk of progression [Time frame: 1 year after surgery]
Secondary outcome measures (12)
  • Visual acuity [Time frame: 3 month after surgery]
  • Visual acuity [Time frame: 6 month after surgery]
  • Visual acuity [Time frame: 1 year after surgery]
  • Visual acuity [Time frame: 2 years after surgery]
  • Visual acuity [Time frame: 5 years after surgery]
  • Risk of progression [Time frame: 1 month after surgery]
  • Risk of progression [Time frame: 3 months after surgery]
  • Risk of progression [Time frame: 6 months after surgery]
  • Risk of progression [Time frame: 2 years after surgery]
  • Risk of progression [Time frame: 5 years after surgery]
  • Depth of demarcation line (OCT) [Time frame: 1 month after surgery]
  • Depth of demarcation line (confocal microscopy) [Time frame: 1 month after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Department of Ophhtalmology, University of Oslo — Oslo

Identifiers

NCT: NCT06264024 · 519516

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗