Keratoconus
Conditions
Keywords
keratoconus, cornea, cross linking, UV-light, riboflavin
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 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
Interventions
PROCEDURECCL (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
Sponsors
Suphi Taneri
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany
Exclusion criteria
* Non-ectatic conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 172 to 3396 days | Corrected Visual Acuity after crosslinking at the latest follow up examination |
| Postoperative K Max | 172 to 3396 days | K max after Crosslinking |
| Sphere | 172 to 3396 days | Sphere values after crosslinking at lastest-follow-up |
| Cylinder | 172 to 3396 days | Refractive cylinder after Crosslinking at latest follow-up |
Countries
Germany
Contacts
STUDY_CHAIRSuphi Taneri, MD
Augenklinik am St. Franziskus Hospital
STUDY_DIRECTORBerthold Seitz, MD
University of Homburg, Saar, Germany
STUDY_DIRECTORPhilip Maier, MD
Univer. Freiburg, Germany
STUDY_DIRECTORClaus Cursiefen, MD
Univer. Erlangen, Germany
PRINCIPAL_INVESTIGATORThomas Reinhard, MD
Univers. Freiburg
PRINCIPAL_INVESTIGATORArnd Heiligenhaus, MD
Augenklinik am St.Franzsikus Hospital, Münster
PRINCIPAL_INVESTIGATORWalter Sekundo, MD
Univers. Mainz
PRINCIPAL_INVESTIGATORTheo Seiler, MD
IROC, Zürich
PRINCIPAL_INVESTIGATORAtilla Osvald, MD
Univers Homurg, Saar
PRINCIPAL_INVESTIGATORJan M Vetter, MD
Univers. Mainz
Participant flow
Recruitment details
All eyes included with corneal crosslinking
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 60 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 296 Participants |
| Astigmatismus | 2.35 Diopters STANDARD_DEVIATION 1.57 |
| Corrected Visual Acuity | 0.67 letters read per line STANDARD_DEVIATION 0.36 |
| Cylinder | -2.90 Diopters STANDARD_DEVIATION 2.28 |
| Endothelial Cells | 2818 cells/mm^2 STANDARD_DEVIATION 351 |
| K1 | 49.7 Diopters STANDARD_DEVIATION 11.09 |
| K2 | 55 Diopters STANDARD_DEVIATION 14.33 |
| Kmax | 53.2 Diopters STANDARD_DEVIATION 5.19 |
| Pachymetry Thinnest | 473 µm STANDARD_DEVIATION 40 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 117 Participants |
| Sphere | -0.88 Diopters STANDARD_DEVIATION 4.38 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 70 | 0 / 20 |
| other Total, other adverse events | 6 / 33 | 5 / 70 | 0 / 20 |
| serious Total, serious adverse events | 0 / 33 | 0 / 70 | 0 / 20 |
Outcome results
None listed