NCT00821223已完成不适用
Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial
Iladevi Cataract and IOL Research Center1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2009年2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
- 420
- 试验地点
- 1
- 主要终点
- immediate unaided and aided visual acuity
研究概览
简要总结
Hypothesis :
Phacoemulsification is superior to SICS with regards to:
- Immediate unaided high and low contrast visual performance
- Its impact on quality of life.
详细描述
Phacoemulsification procedure
- Infiniti Vision System with Software 2.03 or higher, OZil handpiece (HP)
- Anaesthesia: topical
- Incision: temporal clear corneal 2.2 mm single plane
- CCC and hydrodissection, sculpting and division using step by step chop in situ and lateral separation, I/A.
- Single-piece AcrySof IOL (SN60WF) in the bag
SICS procedure
- Anaesthesia: peribulbar
- Incision: superior scleral tunnel 6.5 to 7 mm
- CCC and hydrodissection
- Nuclear expression: blumenthal technique using anterior chamber maintainer, manual cortical clean-up
- Single-piece PMMA (MZ60BD) in the bag
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective subjects should be diagnosed with senile cataract. Subject must require extraction of cataract in one eye followed by implantation of an AcrySof (SN60WF) or PMMA (MZ60BD) posterior chamber intraocular lens.
- •Pupil dilation equal or greater to 7 mm after mydriasis.
- •Patients undergoing cataract surgery for the first eye.
- •Visual prognosis equal or greater to 6/12.
排除标准
- •Patients with history of ocular pathology, glaucoma, uveitis, high myopia, PEX, or corneal pathology.
- •Patients with traumatic, subluxated and posterior polar cataract.
- •Patients who had previously ocular surgery in the past 6 months prior to the screening visit.
- •Patients with diabetic retinopathy.
- •Patients who are not suitable for follow-up visits.
- •Patients with Fuchs' Dystrophy, Macular Degeneration, Ocular Surface Disease that will interfere with normal recovery.
- •Any patients with significant intra-operative complications will be removed from the overall analysis of the results. All patient data should still be recorded, even if from the "excluded" patient group.
结局指标
主要结局
immediate unaided and aided visual acuity
时间窗: immediate and mid term (12 months)
次要结局
- Assessment of unaided and aided low contrast sensitivity(3 and 12 months)
- Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation(day 1, 1 week)
- To assess improvement in quality of life(3 and 12 months)
研究者
研究点 (1)
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