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Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Phase 3
Completed
Conditions
Keratoconus
Interventions
Registration Number
NCT03187912
Lead Sponsor
Medical University of Vienna
Brief Summary

Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation intensities and shorter irradiation times have been introduced. In addition, new riboflavin solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated corneal collagen cross-linking protocol with different riboflavin solutions.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Progressive Keratoconus
  • Indication for treatment
  • Preoperative Pachymetry > 400
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Exclusion Criteria
  • Pregnancy
  • Re-CXL
  • Keratitis
  • Other visual acuity limiting eye diseases than corneal ectatic diseases
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Riboflavin with HPMCRiboflavinRiboflavin drops with HPMC
Riboflavin with 20% DextranRiboflavinRiboflavin drops with Dextran
Primary Outcome Measures
NameTimeMethod
Kmax12 months

Steepest Keratometry

Secondary Outcome Measures
NameTimeMethod
Postoperative central stromal depth of the Demarcation Line1 month

The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT

LogMAR12 months

Visual Acuity

Trial Locations

Locations (1)

Medical University of Vienna, Department of Ophthalmology

🇦🇹

Vienna, Austria

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