NCT00560651

Brief Summary

Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state. Corneal Cross Linking is designed to

  • increase the cornea's mechanical stability
  • to stop progression of bulging and thinning of the cornea
  • to prevent the need for corneal transplantation Corneal Cross Linking is performed by
  • Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea
  • Illuminating the cornea with UV-light
  • gather long-term results
  • detect rare complications and side-effects
  • evaluate the efficacy in a large number of patients

Trial Health

75
On Track

Trial Health Score

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

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress93%
Nov 2007Nov 2027

Study Start

First participant enrolled

November 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

17 years

First QC Date

November 19, 2007

Last Update Submit

January 9, 2025

Conditions

Keratoconus

Keywords

keratoconuscorneacross linkingUV-lightriboflavin

Outcome Measures

Primary Outcomes (1)

  • Keratometry

    yearly

Secondary Outcomes (2)

  • Slit-lamp biomicroscopical findings

    yearly

  • Best corrected Visual Acuity

    Yearly

Study Arms (1)

1

Cross linked eyes

Procedure: CCL (Corneal Cross Linking)

Interventions

CCL (Corneal Cross Linking)PROCEDURE

Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance

Also known as: Collagen cross linking, Corneal collagen cross linking, CCL, 3C-L
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated with Corneal Cross Linking in Germany

You may qualify if:

  • Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany

You may not qualify if:

  • Non-ectatic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Saar

Homburg, 66421, Germany

Location

Augenklinik am St. Franziskus Hospital

Münster, 48145, Germany

Location

Related Publications (4)

  • Koller T, Seiler T. [Therapeutic cross-linking of the cornea using riboflavin/UVA]. Klin Monbl Augenheilkd. 2007 Sep;224(9):700-6. doi: 10.1055/s-2007-963492. German.

    PMID: 17846959BACKGROUND

  • Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. doi: 10.1097/ICO.0b013e3180334f78.

    PMID: 17457183BACKGROUND

  • Seiler T, Hafezi F. Corneal cross-linking-induced stromal demarcation line. Cornea. 2006 Oct;25(9):1057-9. doi: 10.1097/01.ico.0000225720.38748.58.

    PMID: 17133053BACKGROUND

  • Wollensak G, Aurich H, Pham DT, Wirbelauer C. Hydration behavior of porcine cornea crosslinked with riboflavin and ultraviolet A. J Cataract Refract Surg. 2007 Mar;33(3):516-21. doi: 10.1016/j.jcrs.2006.11.015.

    PMID: 17321404BACKGROUND

Related Links

MeSH Terms

Conditions

KeratoconusCorneal Diseases

Interventions

CefaclorCorneal Cross-Linking

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

CephalexinCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Suphi Taneri, MD

    Augenklinik am St. Franziskus Hospital

    STUDY CHAIR

  • Berthold Seitz, MD

    University of Homburg, Saar, Germany

    STUDY DIRECTOR

  • Philip Maier, MD

    Univer. Freiburg, Germany

    STUDY DIRECTOR

  • Claus Cursiefen, MD

    Univer. Erlangen, Germany

    STUDY DIRECTOR

  • Thomas Reinhard, MD

    Univers. Freiburg

    PRINCIPAL INVESTIGATOR

  • Arnd Heiligenhaus, MD

    Augenklinik am St.Franzsikus Hospital, Münster

    PRINCIPAL INVESTIGATOR

  • Walter Sekundo, MD

    Univers. Mainz

    PRINCIPAL INVESTIGATOR

  • Theo Seiler, MD

    IROC, Zürich

    PRINCIPAL INVESTIGATOR

  • Atilla Osvald, MD

    Univers Homurg, Saar

    PRINCIPAL INVESTIGATOR

  • Jan M Vetter, MD

    Univers. Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2024

Study Completion (Estimated)

November 1, 2027

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations

DE(2)