Clinical Trials Logo
  1. Home
  2. Keratoconus
  3. NCT03187912
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04570020 - Scleral Lens Fitting Using Wide-Field OCT
Recruiting NCT02921009 - McNeel Eye Center Corneal Crosslinking Study N/A
Completed NCT01691651 - Botulinum Toxin A for the Treatment of Keratoconus N/A
Terminated NCT02762253 - Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus. Phase 2
Completed NCT01527708 - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas N/A
Completed NCT01527721 - Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus N/A
Recruiting NCT00841386 - Treatment of Keratoconus Using Collagen Cross-Linking Phase 2/Phase 3
Completed NCT00347074 - A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients N/A
Completed NCT00584285 - Corneal Topographer Fluorescein Patterns
Completed NCT03511495 - Reliability of Topography Measurements in Keratoconus
Not yet recruiting NCT05395650 - Cyanocobalamin as Photosensitizing Agent
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT05019768 - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS N/A
Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting NCT06100939 - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus Phase 3
Completed NCT02444923 - Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders N/A