Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery: Prospective, Multi-center, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Intraocular pressure
研究概览
简要总结
The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical technique than standard filtration surgery. No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a partial-thickness scleral flap. This may reduce surgical time and complications when compared to a standard trabeculectomy.
In some studies it has been found to be safe and effective with few complications, even in high-risk patients. No previous studies have compared filtration surgery with Ex-Press implant to deep sclerectomy.
详细描述
Hypothesis:
In combined procedure (cataract and filtering surgery), the effect of Ex-PRESS device has similar efficacy reducing intraocular pressure than non penetrant deep sclerectomy and with good level of safety.
Objective:
To evaluate and compare the efficacy and safety at 12 months of the filtering surgery with the Ex-PRESS device with that of deep sclerectomy.
Methods:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma. Points a, b and c will be required:
- •Glaucomatous visual field. Defined as the field presenting at least:
- •A group of 3 or more points with p < 5% in the pattern deviation map AND
- •One of them with a p < 1% in the pattern deviation map AND
- •Repeated in at least 2 VF.
- •Glaucomatous optic nerve. Defined as the optic nerve observed in color photographs presenting:
- •Thinning of the neuroretinal rim that can be demonstrated by an alteration in the ISNT rule.
- •Presence of a notch "or"
- •Presence of papillary splinter hemorrhage "or"
- •Presence of a nerve fiber layer defect "or"
- •Cup to disc (C/D) ratio asymmetry > 0.3 that cannot be explained by asymmetry in the optic disc size "or"
- •C/D ratio > 0.8 that cannot be explained by a large optic disc size
- •III or IV angle in Shaffer classification
- •Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance...)
- •Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)
排除标准
- •Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect < -20 dB)
- •Previous glaucoma surgery
- •Previous intraocular ocular surgery
结局指标
主要结局
Intraocular pressure
时间窗: Up to 12 months
mmHg
次要结局
- Number of hypotensive medications needed(Up to 12 months)
- Success rate at IOP <18(Up to 12 months)
- Number of participants with adverse events assesed by questionare in case report file.(Up to 12 months)