JPRN-UMIN000017727已完成未知
Corrected VA with Long Term Follow up after AcrySof IOL Implantation - Corrected VA with Long Term Follow up after AcrySof IOL Implantation
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
The mean change in logMAR best-corrected visual acuity from baseline at the long-term post-implantation follow-up visit was 0.01, 0.04, and -0.01 in the AcrySof, silicone, and PMMA groups, respectively. The upper limit of 97.5% one-sided confidence interval of the difference in the change in best-corrected visual acuity between the AcrySof group and each control group was +0.01 logMAR for the silicone group and +0.07 logMAR for the PMMA group, both of which were lower than the non-inferiority margin of +0.1 logMAR.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patient who has the following complications that may have an impact on visual acuity at the time of the prospective visit in study eye. -Glaucoma -Diabetic retinitis -Ocular inflammatory disease; scleritis, uveitis, herpes corneae, etc. -Retinal detachment -Abnormal retina and fovea; Macular degeneration, retinal disease -Corneal disease, corneal endothelial cell loss, etc. -History of keratoplasty -Ocular trauma -Intraocular surgery post IOL implantation Occur with post capsular Opacification. Eyes that had YAG laser performed or with peripheral opacification (outside the photopic pupil size) will be allowed in the study 2)Previous refractive surgery in study eye 3)Previous IOL exchange in study eye 4)Disqualified by the investigator or the sub investigator because of systemic or ophthalmic diseases
研究者
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