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NCT03187912 Clinical Trial

Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Keratoconus Clinical Trial

Official title:
Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03187912
Other study ID # 1390/2016
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 19, 2016
Est. completion date March 30, 2020

Study information
Verified date March 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Medical University of Vienna, Department of Ophthalmology Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kmax Steepest Keratometry 12 months
Secondary Postoperative central stromal depth of the Demarcation Line The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT 1 month
Secondary LogMAR Visual Acuity 12 months
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