跳至主要内容
临床试验/NCT01818037
NCT01818037已完成不适用

A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

Iladevi Cataract and IOL Research Center1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Glaucoma following cataract surgery

研究概览

简要总结

Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.

In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery.

In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes.

Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.

研究设计

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

入排标准

年龄范围
1 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Presence of microphthalmos and congenital cataract.
  • Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes

排除标准

  • Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded.

结局指标

主要结局

Glaucoma following cataract surgery

时间窗: 45 months postoperative

次要结局

  • Posterior synechiae(45 months postoperatively)
  • visual axis obscuration(45 months)
  • axial length rate of growth(45 months postoperatively)
  • central corneal thickness(45 months postoperatively)
  • visual acuity(45 months postoperatively)

研究者

发起方
Iladevi Cataract and IOL Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abhay R. Vasavada

Director, Iladevi Cataract and IOL Research Center

Iladevi Cataract and IOL Research Center

研究点 (1)

Loading locations...

相似试验

Long-term Postoperative Outcomes After Bilateral... | 临床试验