Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Mean IOP at 6 months
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.
详细描述
Background: Trabeculectomy with adjunctive use of Mitomycin C (Trab MMC) is the standard incisional procedure to lower intraocular pressure (IOP) in adults with open angle glaucoma (OAG). Trab MMC has been shown to effectively lower IOP, however, it can be associated with a number of serious complications, such as hypotony maculopathy, choroidal effusion or hemorrhage, and endophthalmitis, as well as less serious complications that may affect vision related quality of life such as bleb dysesthesia.
A newer technology, referred to as the Trabectome (NeoMedix Corp., San Juan Capistrano, CA), removes an arc of trabecular meshwork and inner wall of Schlemm's canal with microcautery and appears to lower IOP effectively with fewer and less serious complications than Trab MMC. However, more studies are needed to determine the long term safety and efficacy of this relatively new procedure.
In addition, for OAG patients with visually significant cataracts, either Trab MMC or Trabectome can be combined with cataract surgery.
Study Objective: To compare the efficacy and safety of Trabectome versus Trab MMC, in combination with cataract extraction by phacoemulsification and intraocular lens implant, for control of IOP in OAG, including pseudoexfoliative glaucoma.
Methods: Single center, single surgeon, prospective randomized controlled trial. A total of 52 eligible participants, 26 per study arm would need to be recruited for 90% power. One eye per study patient will be enrolled and randomized to Trabectome combined with cataract surgery (Trabectome-IOL) or Trab MMC combined with cataract surgery (Trab-IOL).
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-85 years
- •Open angle glaucoma (including pseudo exfoliative glaucoma)
- •Open angles (≥ Shaffer grade II)
- •Inadequately controlled IOP requiring surgical intervention
- •Visually significant cataract
- •Willing to complete quality of life questionnaires
- •Capable of informed consent and available for at least 1 year follow-up
排除标准
- •Any form of angle closure glaucoma
- •Secondary open angle glaucomas
- •Absence of clear angle landmarks on gonioscopy
- •Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
- •Previous angle surgery or filtering procedure
- •Steroid use within the preceding 3 months
- •Presence of significant co-morbidities
研究组 & 干预措施
Trabectome-IOL
Combined Trabectome and cataract extraction with intraocular lens insertion
干预措施: Trabectome-IOL (Procedure)
Trab-IOL
Combined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion
干预措施: Trab-IOL (Procedure)
结局指标
主要结局
Mean IOP at 6 months
时间窗: 6 months
Surgical complication rates
时间窗: intraoperative and postoperative up to 12 months
次要结局
- Mean number of glaucoma medications(12 months)
- Visual acuity(12 months)
- Need for additional laser (excluding suture lysis) and surgical interventions(12 months)
- Mean difference in IOP from baseline to 6 months(6 months)
- Mean IOP at 12 months(12 months)
- Quality of life measures(preoperative and postoperative at 6 and 12 months)
研究者
Karim Damji
Professor
University of Alberta