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Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus (CCL)

Primary Purpose

Keratoconus

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Riboflavin/UVA crosslinking
Sham treatment
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Cross linking, Riboflavin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Only early Keratoconus (Contact lens fitting)
  • Progression of Ametropia.
  • Corneal thickness > 450µm

Exclusion Criteria:

  • Further ophthalmic diseases
  • History of ocular surgery
  • Pregnancy, brest feeding
  • Allergy against Riboflavin
  • End stage Keratoconus

Sites / Locations

  • University Eye Hospital Freiburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Keratoconus progression
Endothelial cell loss

Secondary Outcome Measures

Full Information

First Posted
February 20, 2008
Last Updated
January 16, 2013
Sponsor
University Hospital Freiburg
Collaborators
Peschke Meditrade, GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00626717
Brief Title
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
Acronym
CCL
Official Title
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg
Collaborators
Peschke Meditrade, GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression. Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be. Methods: Randomised, placebo controlled, double blinded, multicenter trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Cross linking, Riboflavin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Riboflavin/UVA crosslinking
Intervention Description
Removal of epithelium. Riboflavin eye drops. UVA exposure.
Intervention Type
Procedure
Intervention Name(s)
Sham treatment
Intervention Description
Fluorescein eye drops. Exposure with blue light
Primary Outcome Measure Information:
Title
Keratoconus progression
Time Frame
3 years
Title
Endothelial cell loss
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only early Keratoconus (Contact lens fitting) Progression of Ametropia. Corneal thickness > 450µm Exclusion Criteria: Further ophthalmic diseases History of ocular surgery Pregnancy, brest feeding Allergy against Riboflavin End stage Keratoconus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Maier, MD
Organizational Affiliation
University Eye Hospital, Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Hospital Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26194634
Citation
Lang SJ, Messmer EM, Geerling G, Mackert MJ, Brunner T, Dollak S, Kutchoukov B, Bohringer D, Reinhard T, Maier P. Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus. BMC Ophthalmol. 2015 Jul 21;15:78. doi: 10.1186/s12886-015-0070-7.
Results Reference
derived

Learn more about this trial

Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

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