摘要
背景:白内障超声乳化摘除联合人工晶状体植入已成为老年性白内障患者复明的公认治疗方法。理想的人工晶体应具有良好的生物相容性及良好的分辨率、无球面差等。Acri.LISA366D多焦点非球面人工晶体作为较晚出现的折射/衍射型多焦点人工晶体之一,有别于传统的多焦点人工晶体,其独特的光学设计在提高患者全程视力的同时,还可以减少入射光线的散射及眩光、光晕的发生。目的:比较Tecnis Z9001衍射型多焦点非球面人工晶体与Acri.LISA366D折射/衍射型多焦点非球面人工晶体植入老年性白内障患者后的生物相容性及视力。方法:试验为前瞻性、单中心、随机、双盲、平行对照研究,在中国青海,青海大学附属医院完成;将符合纳入标准的50-80岁老年性白内障患者40例随机植入TecnisZ 9001衍射型多焦点非球面人工晶体(n=20)或Acri.LISA366D折射/衍射型多焦点非球面人工晶体(n=20)。研究方案取得中国青海大学附属医院伦理委员会的书面批准(批准号:QHY1107K),且符合世界医学会制订的《赫尔辛基宣言》,并已在ClinicalT rials.gov注册(NCT02966496)。患者或及监护人对试验内容知情同意。结果与结论:试验的主要结局为人工晶体植入后发生生物相容性问题的百分率;次要结局为视力和屈光改变及并发症发生百分率;试验访视时间点为人工晶体植入后1,3,6个月,1和2年。试验对比分析TecnisZ 9001非球面人工晶体与Acri.LISA366D多焦点非球面人工晶体植入老年白内障患者后的生物相容性及对视觉质量的改善程度,从而为老年性白内障患者选择人工晶体植入物提供依据。
BACKGROUND：Phacoemulsification with intraocular lens （IOL） implantation has become a wel-established treatment for senile cataract. The ideal IOL is characterized by good biocompatibility and resolution, with no spherical aberration. The Acri.LISA 366D is a refractive/diffractive multifocal IOL that differs from traditional multifocal IOLs. Its unique optical design can improve the patient＆#39;s vision and reduce incident ray scattering, glare and halo. OBJECTIVE：To perform a comparative analysis between the Acri.LISA 366D and the Tecnis Z9001 diffractive multifocal IOL, to determine if there are any differences in biocompatibility and improvement in visual function. METHODS：A prospective, single-center, randomized, double-blind, paral el-control ed study wil be conducted at the Affiliated Hospital of Qinghai University in China. Forty cataract patients aged 50–80 years wil be randomly assigned to either the Acri.LISA 366D or Tecnis Z9001 IOL （n=20 per group）. This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital in China （approval No. QHY1107K） and wil be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment wil be obtained from each patient or their guardians. This trial was registered at ClinicalTrials.gov （NCT02696496）. RESULTS AND CONCLUSION：The primary outcome of the trial is to investigate the biocompatibility of the IOL after implantation. The secondary outcomes include visual acuity, refractive changes and the presence of any complications. Outcome measures wil be evaluated at 1, 3, 6, 12 and 24 months after IOL implantation. It is anticipated that the data col ected from this trial wil provide evidence for IOL selection in senile cataract patients.
出处
《中国组织工程研究》
CAS
北大核心
2016年第47期7139-7144,共6页
Chinese Journal of Tissue Engineering Research
基金
青海省科技支撑计划项目~~
