Original articleA Randomized, Controlled Trial of Corneal Collagen Cross-Linking in Progressive Keratoconus: Three-Year Results
Section snippets
Study Design
This was a prospective, unmasked, randomized controlled trial conducted at the Royal Victorian Eye & Ear Hospital and the Centre for Eye Research Australia, Melbourne, Australia, commencing in 2006. The aim of the study was to assess the efficacy and safety of CXL in the treatment of progressive keratoconus. Approval was obtained from the hospital's Human Research and Ethics Committee, and the conduct of this study adhered to the tenets of the Declaration of Helsinki. The trial is registered
Results
Recruitment for the trial was completed in 2009 with 100 eyes randomized to control (50 eyes) and treatment (50 eyes) groups. Six eyes were excluded from analysis: 4 eyes (3 in the treatment group, 1 in the control group) withdrew from the trial before any follow-up data were obtained; 1 patient was pregnant at the time of her 3-year follow-up appointment, and 1 eye had a delay in treatment date, with only 2-year follow-up data available at the time of preparation of this manuscript.
This
Discussion
Corneal collagen cross-linking is often described as the most promising innovation in the treatment of progressive keratoconus in recent years. The growing interest in CXL is reflected in the rapid increase in publications since the first report by Spoerl et al4 in 1998. A keyword search using PubMed (http://www.ncbi.nlm.nih.gov/pubmed) accessed on September 6, 2013, using the terms collagen cross-linking and keratoconus yielded 323 citations, 90% of which were published in the past 4 years.
Acknowledgments
The authors thank Mario Constantinou for his orthoptic work, patient management, and administrative support during the conduct of the trial.
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Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Supported by the Royal Victorian Eye and Ear Hospital Research Committee, Melbourne, Australia; Eye Research Australia Foundation, Melbourne, Australia; and Keratoconus Australia, Melbourne, Australia. Dr. Wittig-Silva is supported by a scholarship from the Faculty of Medicine, University of Melbourne, Melbourne, Australia, and the Contact Lens Society of Australia, Sydney, Australia. None of the funding organizations had any role in the design or conduct of this research. The UV-X device is on loan from the Institute of Refractive and Ophthalmic Surgery. The Centre for Eye Research Australia receives operational infrastructure support from the Victorian government.