Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Overview

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.

Full Title of Study: “Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2020

Interventions

  • Drug: Riboflavin
    • Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively

Arms, Groups and Cohorts

  • Active Comparator: Riboflavin with 20% Dextran
    • Riboflavin drops with Dextran
  • Active Comparator: Riboflavin with HPMC
    • Riboflavin drops with HPMC

Clinical Trial Outcome Measures

Primary Measures

  • Kmax
    • Time Frame: 12 months
    • Steepest Keratometry

Secondary Measures

  • Postoperative central stromal depth of the Demarcation Line
    • Time Frame: 1 month
    • The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT
  • LogMAR
    • Time Frame: 12 months
    • Visual Acuity

Participating in This Clinical Trial

Inclusion Criteria

  • Progressive Keratoconus – Indication for treatment – Preoperative Pachymetry > 400 Exclusion Criteria:

  • Pregnancy – Re-CXL – Keratitis – Other visual acuity limiting eye diseases than corneal ectatic diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gerald Schmidinger, Ass. Prof. PDDr. – Medical University of Vienna

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