Refractive Error — International Multicenter Study on SMILE Surgery
Citation(s)
Li X, Wang Y, Dou R Aberration compensation between anterior and posterior corneal surfaces after Small incision lenticule extraction and Femtosecond laser-assisted laser in-situ keratomileusis. Ophthalmic Physiol Opt. 2015 Sep;35(5):540-51. doi: 10.1111/opo.12226. Epub 2015 Jun 18.
Wang Y, Bao XL, Tang X, Zuo T, Geng WL, Jin Y [Clinical study of femtosecond laser corneal small incision lenticule extraction for correction of myopia and myopic astigmatism]. Zhonghua Yan Ke Za Zhi. 2013 Apr;49(4):292-8. Chinese.
Wei S, Wang Y Comparison of corneal sensitivity between FS-LASIK and femtosecond lenticule extraction (ReLEx flex) or small-incision lenticule extraction (ReLEx smile) for myopic eyes. Graefes Arch Clin Exp Ophthalmol. 2013 Jun;251(6):1645-54. doi: 10.1007/s00417-013-2272-0. Epub 2013 Feb 7. Erratum in: Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2495-7.
Wu D, Wang Y, Zhang L, Wei S, Tang X Corneal biomechanical effects: small-incision lenticule extraction versus femtosecond laser-assisted laser in situ keratomileusis. J Cataract Refract Surg. 2014 Jun;40(6):954-62. doi: 10.1016/j.jcrs.2013.07.056. Epub 2014 Apr 18.
Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015 Jan 24;15:8. doi: 10.1186/1471-2415-15-8.
International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
