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NCT Number: NCT00560651

German Corneal Cross Linking Register

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Saar, Homburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-ectatic conditions

Treatment and study plan

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

Other names: Collagen cross linking, Corneal collagen cross linking, CCL, 3C-L

Primary outcomes

  1. Visual Acuity

    Time frame: 172 to 3396 days

    Corrected Visual Acuity after crosslinking at the latest follow up examination

  2. Postoperative K Max

    Time frame: 172 to 3396 days

    K max after Crosslinking

  3. Sphere

    Time frame: 172 to 3396 days

    Sphere values after crosslinking at lastest-follow-up

  4. Cylinder

    Time frame: 172 to 3396 days

    Refractive cylinder after Crosslinking at latest follow-up

Other outcomes

  1. Endothelial Cell Density

    Time frame: 172 to 3396 days

    Endothelial cell density after Crosslinking at latest follow-up

Sponsors and collaborators

Lead sponsor

Suphi Taneri

Other

Registry information

Important dates

Study start
2007
Primary completion
2024
Study completion
2027
First posted
Nov 20, 2007
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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