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临床试验/NCT04335825
NCT04335825已完成不适用

Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.

Medical University of Bialystok0 个研究点目标入组 81 人开始时间: 2016年1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
81
主要终点
IOP

研究概览

简要总结

The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up

详细描述

Trabeculectomy and implantation of the Ex-Press device belong to the same group of anti-glaucoma procedures improving subconjunctival outflow. The most frequently performed glaucoma surgery of choice is still trabeculectomy, although the less invasive implantation of the Ex-Press device is also an effective alternative. Despite the wide application of these two techniques, their impact on postoperative refraction is not entirely known. Quite often, in the early postoperative period there is a decrease in visual function, which is short-term, although there are reports that it can last up to a year after surgery. It can be caused by a reduction in IOP, as well as the direct effect of trabeculectomy on corneal topography, and thus on postoperative astigmatism and refractive error. The occurrence of astigmatism after trabeculectomy has been widely documented Combined operations of implanting the ExPress implant with cataract phacoemulsification differ from phacotrabeculectomy in that, they do not require cutting of the sclera, cutting the limbus and using a punch.

The purpose of our research was to compare the phacotrabeculectomy and phacoemulsification combined with Express device implantation in terms of incidence of postoperative astigmatism in a prospective randomized study, and to attempt to determine what factors determine its size.

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
None

入排标准

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

入选标准

  • Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery.
  • Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP >21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment.
  • Additional inclusion criteria were as follows: well documented progression of visual field defects, significant diurnal variations in the IOP, poor patient compliance, and allergy to topical drugs.

排除标准

  • Lack of consent to participate in the study,
  • History of eye surgery or laser procedures within the eye,
  • Closed or narrow angle glaucoma,
  • Diabetes,
  • Advanced macular degeneration
  • Active inflammatory disease.

结局指标

主要结局

IOP

时间窗: baseline and six months after surgery

the change in the level of intraocular pressure

次要结局

  • Best corrected visual acuity (BCVA)(baseline and six months after surgery)
  • astigmatism(baseline and six months after surgery)

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Sponsor

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