Riboflavin Mediated Corneal Crosslinking for Stabilizing... | NCT00626717

Studies
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

NCT00626717

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

30Actual

Phase

Phase 2Phase 3

Conditions

Keratoconus

Interventions

Riboflavin/UVA crosslinking
Sham treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 28, 2008

First Posted Date

Feb 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Name	Class
Peschke Meditrade, GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: Riboflavin/UVA crosslinking
2	Sham Comparator		Procedure: Sham treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Riboflavin/UVA crosslinking	Procedure	Removal of epithelium. Riboflavin eye drops. UVA exposure.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Keratoconus progression		3 years
Endothelial cell loss		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Maier, MD	University Eye Hospital, Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital Freiburg		Freiburg im Breisgau	Baden-Wurttemberg	79106	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26194634	Derived	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.

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases