title: Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus.
abstract: BACKGROUND
  Corneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy.
  
  
  METHODS
  The efficacy and safety of corneal cross-linking for halting progression of keratoconus were investigated in a prospective, randomized, blinded, placebo controlled, multicentre trial. Twenty-nine keratoconus patients were randomized in three trial centres. The mean age at inclusion was 28 years. Longitudinal changes in corneal refraction were assessed by linear regression. The best corrected visual acuity, surface defects and corneal inflammation were also assessed. These data were analysed with a multifactorial linear regression model.
  
  
  RESULTS
  A total of 15 eyes were randomized to the treatment and 14 to the control group. Follow-up averaged 1098 days. Corneal refractive power decreased on average (+/-standard deviation) by 0.35 +/- 0.58 dioptres/year in the treatment group. The controls showed an increase of 0.11 +/- 0.61 dioptres/year. This difference was statistically significant (p = 0.02).
  
  
  CONCLUSIONS
  Our data suggest that corneal cross-linking is an effective treatment for some patients to halt the progression of keratoconus. However, some of the treated patients still progressed, whereas some untreated controls improved. Therefore, further investigations are necessary to decide which patients require treatment and which do not.
  
  
  BACKGROUND
  NCT00626717, Date of registration: February 20, 2008.
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. stefan.lang@uniklinik-freiburg.de.
authors.forename: Stefan J
authors.initials: SJ
authors.lastname: Lang
authors.affiliation: Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany. elisabeth.messmer@med.uni-muenchen.de.
authors.forename: Elisabeth M
authors.initials: EM
authors.lastname: Messmer
authors.affiliation: Department of Ophthalmology, University Hospital Würzburg, Würzburg, Germany. Geerling@med.uni-duesseldorf.de.|Department of Ophthalmology, Heinrich-Heine-University, Düsseldorf, Germany. Geerling@med.uni-duesseldorf.de.
authors.forename: Gerd
authors.initials: G
authors.lastname: Geerling
authors.affiliation: Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany. Marc.Mackert@med.uni-muenchen.de.
authors.forename: Marc J
authors.initials: MJ
authors.lastname: Mackert
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. Brunner@sehkraft.de.
authors.forename: Tobias
authors.initials: T
authors.lastname: Brunner
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. sylvia.dollak@googlemail.com.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Dollak
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. kutchoukov@abv.bg.|Department of Ophthalmology, University Hospital "Alexandrovska", Sofia, Bulgaria. kutchoukov@abv.bg.
authors.forename: Borislav
authors.initials: B
authors.lastname: Kutchoukov
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. Daniel.Boehringer@uniklinik-freiburg.de.
authors.forename: Daniel
authors.initials: D
authors.lastname: Böhringer
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. thomas.reinhard@uniklinik-freiburg.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Reinhard
authors.affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. philip.maier@uniklinik-freiburg.de.
authors.forename: Philip
authors.initials: P
authors.lastname: Maier
mesh_terms: D000293:Adolescent; D000328:Adult; D003094:Collagen / Q000378:metabolism; D003319:Corneal Stroma / Q000378:metabolism*; D019781:Corneal Topography; D003432:Cross-Linking Reagents; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007640:Keratoconus / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012256:Riboflavin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014466:Ultraviolet Rays; D014792:Visual Acuity / Q000502:physiology
chemical_list: D003432:Cross-Linking Reagents; D017319:Photosensitizing Agents; D003094:Collagen; D012256:Riboflavin