跳至主要内容
临床试验/NCT02089698
NCT02089698已完成4 期

Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study

Hospital Oftalmologico de Brasilia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities

研究概览

简要总结

To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.

详细描述

In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).

The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.

排除标准

  • Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded

研究组 & 干预措施

Reversed tip

Active Comparator

Reversed Kelman tip

干预措施: Mini-flared (Device)

Mini-flared

Experimental

Mini-flared Kelman tip

干预措施: Reversed tip (Device)

结局指标

主要结局

Early Treatment Diabetic Retinopathy (ETDRS) visual acuities

时间窗: 90 days

次要结局

  • Phaco time used(1 day, 90 days)

研究者

发起方
Hospital Oftalmologico de Brasilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

PATRICK FRENSEL DE MORAES TZELIKIS

Principal Investigator

Hospital Oftalmologico de Brasilia

研究点 (2)

Loading locations...

相似试验