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NCT Number: NCT06264024

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophhtalmology, University of Oslo

Oslo, Norway

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corneal collagen cross linking (CXL)

Procedure

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

Transepithelial phototherapeutic keratectomy (t-PTK)

Procedure

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

Primary outcomes

  1. Visual acuity

    Time frame: 1 month after surgery

    Uncorrected and corrected distance visual acuity in logMAR

  2. Risk of progression

    Time frame: 1 year after surgery

    Change in keratometric values

Secondary outcomes

  1. Visual acuity

    Time frame: 3 month after surgery

    Uncorrected and corrected distance visual acuity in logMAR

  2. Visual acuity

    Time frame: 6 month after surgery

    Uncorrected and corrected distance visual acuity in logMAR

  3. Visual acuity

    Time frame: 1 year after surgery

    Uncorrected and corrected distance visual acuity in logMAR

  4. Visual acuity

    Time frame: 2 years after surgery

    Uncorrected and corrected distance visual acuity in logMAR

  5. Visual acuity

    Time frame: 5 years after surgery

    Uncorrected and corrected distance visual acuity in logMAR

  6. Risk of progression

    Time frame: 1 month after surgery

    Change in keratometric values

  7. Risk of progression

    Time frame: 3 months after surgery

    Change in keratometric values

  8. Risk of progression

    Time frame: 6 months after surgery

    Change in keratometric values

  9. Risk of progression

    Time frame: 2 years after surgery

    Change in keratometric values

  10. Risk of progression

    Time frame: 5 years after surgery

    Change in keratometric values

  11. Depth of demarcation line (OCT)

    Time frame: 1 month after surgery

    Measured with corneal optical coherence tomography (OCT)

  12. Depth of demarcation line (confocal microscopy)

    Time frame: 1 month after surgery

    Measured with confocal microscopy

  13. Patient reported outcome measure (PROMs)

    Time frame: 1 month after surgery

    National eye institute Visual Function Questionnaire 25

  14. Patient reported outcome measure (PROMs)

    Time frame: 6 months after surgery

    National eye institute Visual Function Questionnaire 25

  15. Patient reported outcome measure (PROMs)

    Time frame: 2 years after surgery

    National eye institute Visual Function Questionnaire 25

  16. Patient reported pain after surgery

    Time frame: 48 hours after surgery

    Pain the first 48 hours after the surgery graded on visual analogue scale (VAS); 0 to 10 cm.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2034
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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