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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