NCT02088528Unknown不适用
The Ghana Primary Tube Versus Trabeculectomy Study
Tema Christian Eye Center1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Change in intraocular pressure
研究概览
简要总结
Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution.
The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85 years, inclusive
- •Open angle glaucoma. Including primary open angle glaucoma, pseudoexfoliative and pigmentary glaucoma
- •Intraocular pressure 18 - 40 mmHg on maximal tolerated or maximal affordable medical therapy
- •Informed consent given and consent form signed.
排除标准
- •Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits
- •Pregnant or nursing women
- •No light perception vision
- •Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery
- •Previous ocular laser in study eye
- •Iris neovascularisation or proliferative retinopathy
- •Primary angle closure or primary angle closure glaucoma
- •Iridocorneal endothelial syndrome or anterior segment dysgenesis
- •Epithelial or fibrous downgrowth
- •Chronic or recurrent uveitis
- •Steroid-induced glaucoma
- •Severe posterior blepharitis
- •Unwilling to discontinue contact lens use after surgery
- •Previous cyclodestructive procedure
- •Glaucoma secondary to penetrating keratoplasty, trauma, retinal disease/surgery or neovascular disease
- •Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
- •Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
研究组 & 干预措施
Aurolab glaucoma drainage device
Active Comparator
干预措施: Aurolab glaucoma drainage device (Device)
Trabeculectomy with mitomycin-c
Active Comparator
干预措施: Trabeculectomy with mitomycin-c (Procedure)
结局指标
主要结局
Change in intraocular pressure
时间窗: 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years
次要结局
- Complication rates(1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years)
- Visual acuity(1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years)
- Visual field(6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Reoperation for glaucoma(1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years)
- Supplemental medical therapy(1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years)
- Quality of life(1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
研究者
Alex Spratt
Principal Investigator
Tema Christian Eye Center
研究点 (1)
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