Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Corneal Cross Linking is performed by
This register of Corneal Cross Linking procedures performed in Germany serves to
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Cross linked eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Corrected Visual Acuity after crosslinking at the latest follow up examination | 172 to 3396 days |
| Postoperative K Max | K max after Crosslinking | 172 to 3396 days |
| Sphere | Sphere values after crosslinking at lastest-follow-up | 172 to 3396 days |
| Cylinder | Refractive cylinder after Crosslinking at latest follow-up | 172 to 3396 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Cell Density | Endothelial cell density after Crosslinking at latest follow-up | 172 to 3396 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients treated with Corneal Cross Linking in Germany
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saar | Homburg | 66421 | Germany | |||
| Augenklinik am St. Franziskus Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17846959 | Background | 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. | |
| 17457183 | Background | 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. |
| Label | URL |
|---|---|
| Click here for more information about this study: German Register of Corneal Cross Linking | View source |
Not provided
Not provided
All eyes included with corneal crosslinking
| ID | Title | Description |
|---|---|---|
| FG000 | PRK CXL | Crosslinked eyes with previous photorefractive Keratectomy (PRK) |
| FG001 | PTK CXL | Crosslinked eyes with previous phototherapeutic keratectomy |
| FG002 | Manual CXL | Crosslinked eyes with manual abrasion of epithelium |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PRK CXL | Crosslinked eyes with previous photorefractive Keratectomy (PRK) |
| BG001 | PTK CXL | Crosslinked eyes with previous phototherapeutic keratectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | Corrected Visual Acuity after crosslinking at the latest follow up examination | Different numbers due to incomplete measurements during examination | Posted | Geometric Mean | Standard Deviation | letters read per line | 172 to 3396 days | Eyes | Eyes |
|
Up until 3 month post corneal crosslinking
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRK CXL | Crosslinked eyes in combination with previous photorefractive Keratectomy (PRK) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sterile Infiltrates | Eye disorders | Systematic Assessment | A sterile infiltrate is an accumulation of inflammatory cells (such as white blood cells) in tissue that is caused by an immune or inflammatory response, rather than an active, live bacterial, viral, or fungal infection |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anika Förster | Center for Refractive Surgery | +49 251 987789 0 | foerster@refraktives-zentrum.de |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2026 | Apr 23, 2026 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002433 | Cefaclor |
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D002506 | Cephalexin |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Univers. Mainz |
| Principal Investigator |
| Münster |
| 48145 |
| Germany |
| 17133053 | Background | 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. |
| 17321404 | Background | 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. |
| BG002 | Manual CXL | Crosslinked eyes with manual abrasion of epithelium |
| BG003 | Total | Total of all reporting groups |
| Eyes |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Corrected Visual Acuity | Visual Acuity with best manifest refraction measured in decimal scale, archieved by letters read per line | Geometric Mean | Standard Deviation | letters read per line | Eyes |
|
|
| Sphere | Sphere (refraction or spectacle prescription), negative values present myopic refraction, positive values present hyperopic refraction | Mean | Standard Deviation | Diopters | Eyes |
|
|
| Cylinder | Sphere (refraction or spectacle prescription), negative values present myopic refraction, positive values present hyperopic refraction | Mean | Standard Deviation | Diopters | Eyes |
|
|
| Endothelial Cells | Corneal Endothelial cell density, measured in cells per /mm^2 | Mean | Standard Deviation | cells/mm^2 | Eyes |
|
|
| K1 | Corneal Keratometry value of flat meridian, scaled in diopters, measured with Tomograph/Topograph | Mean | Standard Deviation | Diopters | Eyes |
|
|
| K2 | Corneal Keratometry value of steep meridian, scaled in diopters, measured with Tomograph/Topograph | Mean | Standard Deviation | Diopters | Eyes |
|
|
| Kmax | Maximal Corneal Keratometry value, scaled in diopters, measured with Tomograph/Topograph | Mean | Standard Deviation | Diopters | Eyes |
|
|
| Astigmatismus | Corneal Astigmatism (anterior), scaled in diopters, measured with Tomograph/Topograph | Mean | Standard Deviation | Diopters | Eyes |
|
|
| Pachymetry Thinnest | Pachymetry at thinnest point of the cornea, measured with Tomograph/Topograph | Mean | Standard Deviation | µm | Eyes |
|
|
Crosslinked eyes with manual abrasion of epithelium |
|
|
| Primary | Postoperative K Max | K max after Crosslinking | Posted | Mean | Standard Deviation | Diopters | 172 to 3396 days | Eyes | Eyes |
|
|
|
| Primary | Sphere | Sphere values after crosslinking at lastest-follow-up | Posted | Mean | Standard Deviation | Diopters | 172 to 3396 days | Eyes | Eyes |
|
|
|
| Primary | Cylinder | Refractive cylinder after Crosslinking at latest follow-up | Posted | Mean | Standard Deviation | Diopters | 172 to 3396 days | Eyes | Eyes |
|
|
|
| Other Pre-specified | Endothelial Cell Density | Endothelial cell density after Crosslinking at latest follow-up | Posted | Mean | Standard Deviation | Cells/mm^2 | 172 to 3396 days | Eyes | Eyes |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 6 |
| 33 |
| EG001 | PTK CXL | Crosslinked eyes in combination with previous phototherapeutic keratectomy (PTK) | 0 | 70 | 0 | 70 | 5 | 70 |
| EG002 | Manual CXL | Crosslinked eyes with manual abrasion of epithelium | 0 | 20 | 0 | 20 | 0 | 20 |
|
Not provided
Not provided
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
| Male |
|