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

NCT06264024 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-02-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2025-05-01
Completion
2034-02-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264024 on ClinicalTrials.gov