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临床试验/NCT04447157
NCT04447157已完成不适用

The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 9 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
主要终点
Anterior chamber depth

研究概览

简要总结

By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
10 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Microspherophakia was diagnosed and lens diameter<9mm;
  • The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
  • Lens dislocated into the anterior chamber;
  • Lens dislocation caused elevated intraocular pressure (IOP);
  • The lens contacted the corneal endothelium;
  • Cataract;
  • Corneal endothelial cell density>1000/mm2;
  • The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy;
  • There was possible improvement in postoperative visual acuity measured by retinometer.

排除标准

  • The lens is centered and the position of the lens is stable;
  • Glasses can correct the vision obviously;
  • The reason for the elevated IOP was independent with the lens;
  • A high possibility of corneal decompensation after surgery;
  • Fundus function was poor and it is not expected to improve the vision after surgery;
  • Combined with other ocular diseases which were not suitable for IOL implantation;
  • Combined with a systemic disease that the patient cannot tolerate the surgery.

结局指标

主要结局

Anterior chamber depth

时间窗: 6 month postoperation

Anterior chamber depth measured using Ultrasound biomicroscope

Intraocular pressure

时间窗: 6 month postoperation

intraocular pressure measured using non-contact tonometer

PCIOL tilt degree

时间窗: 6 month postoperation

PCIOL tilt degree measured using Ultrasound biomicroscope

PCIOL decentration distance

时间窗: 6 month postoperation

PCIOL decentration distance measured using Ultrasound biomicroscope

Visual function

时间窗: 6 month postoperation

uncorrected distance visual acuity (UDVA) measured using a decimal chart

Endothelial cell density

时间窗: 6 month postoperation

Endothelial cell density was measured by specular microscopy

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

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