Refractive Error Clinical Trial
Official title:
International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery
Verified date | May 2018 |
Source | Tianjin Eye Hospital |
Contact | Yan Wang, director |
wangyan7143[@]vip.sina.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to carry out an international multicenter trial to get more
convincing and valuable results of the SMILE surgery and compare the outcomes between the
SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis)
surgery.
The investigators hope to investigate the differences between the SMILE and the FS-LASIK
surgery comprehensively, including the comparison of visual acuity, refraction, the
correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the
corneal ectasia, the characteristics of the changes of central corneal thickness and the
complications. To meet the demands of a multi center trial, all the examination equipments
should be same in each center, and this will limit the variations within a study
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent; - at baseline, be within the age range of 18 to 45 years old inclusive - normal corneal morphology with no corneal nebula or corneal macula, the range of preoperative K2 (the steep curvature of the 3mm area at the center of cornea) from 38.0 to 47.0 diopter - manifest spherical equivalent of -1.0 to -10.0 diopters (D) - cylindrical diopter no more than -5.0D - refractive diopter maintained stable for more than2 years - preoperative BCVA=0.8, and the scotopic pupil diameter=5.0mm when measured by WASCA analyzer (Carl Zeiss Meditec AG) - picked off soft contact lens for more than 2 weeks - picked off RGP for more than 1 month - preoperative corneal central thickness measured by Pentacam >500µm, non-contact IOP<21mmHg - be willing to comply with the clinical trial visit schedule as directed by the investigator. Exclusion Criteria: - any corneal diseases, corneal operations, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus - corneal macula and obvious pannus; current enrolment in another clinical trial/research project. |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Eye Hospital | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Eye Hospital | Alexandria University, Belgian Ocular Laser Centre, Jinan Mingshui Eye Hospital, Nethradhama Superspeciality Eye Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | corrected visual acuity | change from baseline with EDTRS chart at 6 months | ||
Secondary | uncorrected visual acuity | change from baseline with EDTRS chart at 6 months | ||
Secondary | spherical diopter | change from baseline with manifest refraction at 6 months | ||
Secondary | cylindrical dioptor | change from baseline with manifest refraction at 6 months | ||
Secondary | central corneal thickness | change from baseline with the Pentacam system at 6 months | ||
Secondary | corneal curvature assessed by the Pentacam system | change from baseline with mean Pentacam keratometry at 6 months | ||
Secondary | corneal resistance factor assessed by the Ocular Response Analyzer | change from baseline at 6 months | ||
Secondary | corneal hysteresis assessed by the Ocular Response Analyzer | change from baseline at 6 months | ||
Secondary | deformation amplitude assessed by the Corvis ST system | change from baseline at 6 months | ||
Secondary | spherical aberration | change from baseline with the WASCA system at 6 months | ||
Secondary | coma aberration | change from baseline with the WASCA system at 6 months | ||
Secondary | complication | intraoperative and postoperative at 6 months |
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