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临床试验/NCT02328157
NCT02328157Unknown不适用

Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.

Kagawa University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
The degree of IOL axis rotation from the end of surgery

研究概览

简要总结

Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism.

Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. So far, however, limited information is available on the the stability of axis rotation, astigmatism correction, and improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a 25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show that postoperative IOL axis stability is similar to that reported for cataract surgery alone in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.

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

性别
All
接受健康志愿者

入选标准

  • Preoperative corneal cylinder of more than 0.75 diopter
  • Symptomatic idiopathic epiretinal membrane
  • Symptomatic cataract

排除标准

  • Severe media opacity other cataract
  • Eyes with other retinal disease, such as diabetic retinopathy, retinal vein occlusion, rhegmatogenous retinal detachment

研究组 & 干预措施

Cataract with ERM and astigmatism

Experimental

Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.

干预措施: Vitrectomy with cataract surgery and toric IOL (Device)

Cataract with ERM and astigmatism

Experimental

Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.

干预措施: Vitrectomy with cataract surgery and common IOL (Device)

结局指标

主要结局

The degree of IOL axis rotation from the end of surgery

时间窗: Six months after the inplantation

次要结局

未报告次要终点

研究者

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

Akitaka Tsujikawa

Professor and Chairman

Kagawa University

研究点 (2)

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