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临床试验/CTRI/2010/091/000195
CTRI/2010/091/000195未知不适用

Comparitive study of visual performance following implantation of square edge hydrophobic acrylic and silicone intraocular lenses in pediatric cataract

Dr Jagat Ram1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 待定

试验速览

阶段
不适用
发起方
入组人数
41
试验地点
1
主要终点
visual axis opacification (VAO), PCO, membranectomy rates for significant VAO

研究概览

简要总结

This prospective clinical study was conducted among children (age 1month to 8 years) with congenital/developmental cataract in a tertiary care centre. The children were randomly divided into two groups. All participants underwent phacoaspiration, primary posterior capsulotomy and anterior vitrectomy. Group A (n=21) was implanted with acrylic hydrophobic, AcrySof SA60AT® intra ocular lens (IOL), where as Group B (n=20) was implanted with silicone, Tecnis Z9000® IOL. The children were evaluated for anterior chamber reaction, IOL position, posterior capsular opacification (PCO), intraocular pressure (IOP), best corrected visual acuity (BCVA), corneal status and refractive errors.Postoperatively, two eyes in each group had significant anterior chamber reaction with fibrin membrane formation. Cornea was clear in both groups. IOLs were in the capsular bag in all but one eye in both groups. Seven eyes in the acrylic group and six eyes in the silicone group achieved visual acuity of 20/40 or better. None of the eye had glaucoma. Best corrected visual acuity (BCVA) at one year was similar in both groups. In the acrylic hydrophobic group, 14 eyes needed hypermetropic correction and 7 eyes were myopic where as in the silicone group 10 eyes had myopia and 10 eyes had hypermetropia at 1 year postoperatively. Posterior capsule opacification at one year postoperative was more common in eyes implanted with acrylic hydrophobic IOL (5 eyes) than in silicone IOL (2 eyes).

研究设计

分配方式
Random Number Table
盲法
Not Applicable

入排标准

入选标准

  • (a) Children, aged one month to eight years, with visually significant congenital or developmental cataract.
  • (b) Partial or dense, visually significant cataract, involving 3 mm or more of the central visual axis.

排除标准

  • (a) Presence of an associated ocular disease such as microphthalmia, microcornea, glaucoma, uveitis, complicated cataract, posterior lenticonus, coloboma, subluxated lens, retinal lesions like retinal detachment, retinal holes etc.
  • (b) Suspected pre existing posterior capsular defects like traumatic cataract (c) Systemic diseases (d) Children in whom the axial length of the eye < 17mm.

结局指标

主要结局

visual axis opacification (VAO), PCO, membranectomy rates for significant VAO

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
Dr Jagat Ram

研究点 (1)

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