German Corneal Cross Linking Register

NCT ID: NCT00560651

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2027-11-30

Brief Summary

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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

1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea
2. Illuminating the cornea with UV-light

This register of Corneal Cross Linking procedures performed in Germany serves to

* gather long-term results
* detect rare complications and side-effects
* evaluate the efficacy in a large number of patients

Detailed Description

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Conditions

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Keratoconus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Cross linked eyes

CCL (Corneal Cross Linking)

Intervention Type 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

Interventions

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CCL (Corneal Cross Linking)

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

Intervention Type PROCEDURE

Other Intervention Names

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Collagen cross linking Corneal collagen cross linking CCL 3C-L

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-ectatic conditions
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suphi Taneri

OTHER

Sponsor Role lead

Responsible Party

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Suphi Taneri

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Suphi Taneri, MD

Role: STUDY_CHAIR

Augenklinik am St. Franziskus Hospital

Berthold Seitz, MD

Role: STUDY_DIRECTOR

University of Homburg, Saar, Germany

Philip Maier, MD

Role: STUDY_DIRECTOR

Univer. Freiburg, Germany

Claus Cursiefen, MD

Role: STUDY_DIRECTOR

Univer. Erlangen, Germany

Thomas Reinhard, MD

Role: PRINCIPAL_INVESTIGATOR

Univers. Freiburg

Arnd Heiligenhaus, MD

Role: PRINCIPAL_INVESTIGATOR

Augenklinik am St.Franzsikus Hospital, Münster

Walter Sekundo, MD

Role: PRINCIPAL_INVESTIGATOR

Univers. Mainz

Theo Seiler, MD

Role: PRINCIPAL_INVESTIGATOR

IROC, Zürich

Atilla Osvald, MD

Role: PRINCIPAL_INVESTIGATOR

Univers Homurg, Saar

Jan M Vetter, MD

Role: PRINCIPAL_INVESTIGATOR

Univers. Mainz

Locations

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University of Saar

Homburg, , Germany

Site Status

Augenklinik am St. Franziskus Hospital

Münster, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17846959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17457183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17133053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17321404 (View on PubMed)

Related Links

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http://www.freiheit-ohne-brille.de

Click here for more information about this study: German Register of Corneal Cross Linking

Other Identifiers

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CCL

Identifier Type: -

Identifier Source: org_study_id

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