跳至主要内容
临床试验/NCT03674840
NCT03674840已完成不适用

Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Uncorrected visual acuity

研究概览

简要总结

The study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric MIOL [SBL-3 Lenstec; +3.00 diopters (D)], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for SBL-3.

详细描述

SBL-3 has been proved to provide patients with good near, intermediate and distant visual acuity, but there is not much study on the impact of SBL-3 position on postoperative visual acuity.The regional refractive design of SBL-3 means it could be affected by pupil center shift (described by angle kappa: the difference between visual axis and pupil axis), the investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%) in the pupil center could yield both good distant and near postoperative visual acuity postoperatively. Therefore, the investigators designed the implantation by placing the IOL based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil center close to 50:42. In this study, the investigators assessed the optical quality in patients with SBL-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons with information for choosing appropriate implantation position for optimum postoperative satisfaction of SBL-3.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
54 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age related cataract
  • underwent bilateral cataract surgery and SBL-3 implantation
  • corneal astigmatism <1.5D

排除标准

  • patients with active ocular inflammation
  • neuro-ophthalmic disease and macular disease
  • previous corneal or intraocular surgery, corneal opacities or disease
  • patients had surgical complications, pupillary trauma, inability to place the lens in the capsular bag
  • IOL tilt or decentration deviated from intraoperative positioning
  • difficulties with examinations and follow-up

结局指标

主要结局

Uncorrected visual acuity

时间窗: 3 months postoperatively

Comparison of uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity were measured at 5m, 80cm and 33cm respectively. All visual acuity measurements were conducted under photopic conditions (85 cd/m2) and at 100% contrast in design group and control group.

次要结局

  • Defocus curve(3 months postoperatively)
  • Optical quality(3 months postoperatively)
  • Contrast sensitivity(3 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Qi

Professor

Peking University Third Hospital

研究点 (1)

Loading locations...

相似试验

Comparison of Optical Quality With Different... | 临床试验