Prospective Study on Ex-PRESS Implantation Combined With Phacoemulsification in Primary Angle-closure Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
Primary angle-closure glaucoma (PACG) is common, phacotrabeculectomy is associated with a significant risk of complications.The Ex-PRESS shunt was introduced as a modification to trabeculectomy, with the theoretical advantages of reduced complications.Our purpose is to perform a prospective study to evaluate the clinical outcomes and safety of the Ex-PRESS shunt with cataract surgery for PACG patients coexisting cataract.
详细描述
The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy mainly for patients with primary open-angle glaucoma.It has been proved to be as effective as trabeculectomy in a series of researches. However the early postoperative complication of Ex-PRESS implantation is less frequent compared with trabeculectomy. Ex-PRESS was designed initially for open angle glaucoma, gradually some scholars used it in refractory postpenetrating keratoplasty glaucoma and in vitrectomized glaucoma,which showed that Ex-PRESS shunt implantation was an effective procedure too. We analyzed the clinical efficacy and safety of combined phacoemulsification and Ex-PRESS implantation for PACG patients with cataract. Data was recorded before surgery and postoperatively at 1 week and 1, 3, 6, 12,18,24,30,36 months，which included intraocular pressure (IOP), best corrected visual acuity (BCVA), number of medications, complications, corneal endothelial cell density and anterior segment optical coherence tomography(AS-OCT). Efficacy was assessed by IOP values and success rates. Complete success was determined by IOP between 5 and 21mmHg without medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •The presence of PACG, angle peripheral anterior synechia (PAS) more than 180 degrees.
- •An indication for glaucoma filtering surgery based on uncontrolled IOP or progressive vision field defect despite antiglaucoma medications.
- •Mean vision field defect greater than 15dB.
- •The presence of a clinically significant decrease of visual acuity as a result of cataract, usually BCVA less than 0.6.
排除标准
- •Patients unable to give informed consent.
- •Ocular infection or inflammation in the study eye in the 3 months prior to enrollment.
- •Intraocular surgery in the study eye in the 3 months prior to enrollment.
研究组 & 干预措施
Ex-PRESS and phacoemulsification
A treatment session of PACG coexisting cataract treated with phacoemulsification combined with P50 Ex-PRESS miniature glaucoma device (Alcon Laboratories, Fort Worth, Texas, USA).
干预措施: Ex-PRESS and phacoemulsification (Procedure)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: 36 months
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
次要结局
- Intraocular pressure (IOP)(2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.)
- Best corrected visual acuity (BCVA)(2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.)
- Number of intraocular pressure lowering medications(2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.)
- Corneal endothelial cell density(3 months)
- Angle opening distance(AOD500)(3 months)
- Anterior chamber distance(ACD)(3 months)
研究者
yin ying zhao
MD
Wenzhou Medical University