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Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Primary Purpose

Keratoconus

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Riboflavin
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Riboflavin with 20% Dextran

Riboflavin with HPMC

Arm Description

Riboflavin drops with Dextran

Riboflavin drops with HPMC

Outcomes

Primary Outcome Measures

Kmax
Steepest Keratometry

Secondary Outcome Measures

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
LogMAR
Visual Acuity

Full Information

First Posted
June 12, 2017
Last Updated
March 2, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03187912
Brief Title
Accelerated Corneal Cross-linking With Different Riboflavin Solutions
Official Title
Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riboflavin with 20% Dextran
Arm Type
Active Comparator
Arm Description
Riboflavin drops with Dextran
Arm Title
Riboflavin with HPMC
Arm Type
Active Comparator
Arm Description
Riboflavin drops with HPMC
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Intervention Description
Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively
Primary Outcome Measure Information:
Title
Kmax
Description
Steepest Keratometry
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Postoperative central stromal depth of the Demarcation Line
Description
The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT
Time Frame
1 month
Title
LogMAR
Description
Visual Acuity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Vienna, Department of Ophthalmology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Accelerated Corneal Cross-linking With Different Riboflavin Solutions

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