NCT00626717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

5.3 years

First QC Date

February 20, 2008

Last Update Submit

January 16, 2013

Conditions

Keratoconus

Keywords

KeratoconusCross linkingRiboflavin

Outcome Measures

Primary Outcomes (2)

  • Keratoconus progression

    3 years

  • Endothelial cell loss

    3 years

Study Arms (2)

1

EXPERIMENTAL
Procedure: Riboflavin/UVA crosslinking

2

SHAM COMPARATOR
Procedure: Sham treatment

Interventions

Riboflavin/UVA crosslinkingPROCEDURE

Removal of epithelium. Riboflavin eye drops. UVA exposure.

1
Sham treatmentPROCEDURE

Fluorescein eye drops. Exposure with blue light

2

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26194634DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Philip Maier, MD

    University Eye Hospital, Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

DE(1)