Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 主要终点
- CDVA
研究概览
简要总结
The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.
详细描述
Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
- •patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
- •documented progression of loss of field of vision,
- •significant daily IOP fluctuations,
- •no cooperation from patient with regard to application of anti-glaucoma treatment,
- •allergy to topical medication
- •written consent to involvement and participation in the study for a period of at least 24 months
排除标准
- •no consent to participation in the study
- •prior surgical and laser procedures in the area of the eye
- •narrow- or closed-angle glaucoma
- •post-inflammatory or post-traumatic secondary glaucoma
- •chronic illness of the cornea or optic nerve
- •advanced macular degeneration
- •active inflammatory process
- •pregnancy
- •systemic steroid therapy
研究组 & 干预措施
phaco and Ex-Press
patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press
干预措施: phacoemulsification with implantation of the Ex-Press (Procedure)
deep sclerectomy, phaco and Ex-press
patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation
干预措施: deep sclerectomy, phacoemulsification, ExPress implantation (Procedure)
结局指标
主要结局
CDVA
时间窗: baseline, and 24th month after surgery
the change in corrected distance visual acuity
IOP
时间窗: baseline, and 24th month after surgery
the change in level of intraocular pressure
number of drugs
时间窗: baseline, and 24th month after surgery
the change in number of antiglaucoma medications
次要结局
- number of complications(in a day of surgery)