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临床试验/NCT05829122
NCT05829122招募中不适用

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty for Aphakia and Traumatic Mydriasis

Changzhou Second People's Hospital affiliated with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
intraocular pressure

研究概览

简要总结

In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, best corrected visual acuity, intraocular pressure, pupil diameter, corneal endothelial cell count, fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage pupilloplasty. The modified iris cerclage pupilloplasty was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • diagnosis of aphakia
  • permanently dilated pupils
  • history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma

排除标准

  • iris defects
  • severe diseases such as cyclodialysis cleft, uncontrolled IOP, retinal detachment
  • poorly controlled systemic diseases such as diabetes and hypertension
  • corneal endothelial cell counts of <1000/mm2
  • <6 months of follow-up

结局指标

主要结局

intraocular pressure

时间窗: 6 months postoperatively

mmHg

pupil diameter

时间窗: 6 months postoperatively

mm

best corrected visual acuity

时间窗: 6 months postoperatively

logMAR

corneal endothelial cell count

时间窗: 6 months postoperatively

cell/mm2

次要结局

未报告次要终点

研究者

发起方
Changzhou Second People's Hospital affiliated with Nanjing Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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