Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus

BMC Ophthalmology

Research Article

Elisabeth M. Messmer¹  Marc J. Mackert¹  Gerd Geerling²  Tobias Brunner³  Daniel Böhringer³  Philip Maier³  Sylvia Dollak³  Stefan J. Lang³  Thomas Reinhard³  Borislav Kutchoukov⁴ 

[1] Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany;Department of Ophthalmology, University Hospital Würzburg, Würzburg, Germany;Department of Ophthalmology, Heinrich-Heine-University, Düsseldorf, Germany;Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany;Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany;Department of Ophthalmology, University Hospital “Alexandrovska”, Sofia, Bulgaria;

关键词: Visual Acuity;    Central Corneal Thickness;    Keratoconus;    Sham Procedure;    Corneal Topography;   

DOI  :  10.1186/s12886-015-0070-7

 received in 2015-03-05, accepted in 2015-07-13,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundCorneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy.MethodsThe 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.ResultsA 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).ConclusionsOur 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.Trial registrationNCT00626717, Date of registration: February 20, 2008.

【 授权许可】

CC BY   
© Lang et al. 2015