The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
详细描述
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.
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
- 否
入选标准
- •glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
- •primary open angle glaucoma
- •primary angle-closure glaucoma
- •pseudoexfoliation glaucoma
- •pigmentary glaucoma
- •traumatic glaucoma
- •neovascular glaucoma
排除标准
- •patients that are pregnant, nursing, or not using adequate contraception
- •any other eye surgery except cataract surgery
- •an infection, inflammation, or any abnormality preventing measurement of eye pressure
- •enrolled in another investigational study
研究组 & 干预措施
Treatment 1(Triesence)
glaucoma surgery with 0.2cc Triesence adjunct.
干预措施: Triesence (Drug)
Treatment 2 (balanced salt solution BSS)
glaucoma surgery with balanced salt solution, the standard technique.
干预措施: balanced salt solution BSS (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 1 day, 1week, 1 month, 3 month and 6 month post-op visits
Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.
次要结局
- Patient Comfort(1 day, 1 week, 1 month, 3 month and 6 month post-op visits)
- Ocular Hypotensive Medications(1 week, 1 month, 3 month, and or 6 month post-op visits)
- Anterior Chamber Inflammation (Flare)(1 month, 3 month and 6 month post-op visits)
- Bleb Appearance(1 day, 1 week, 1 month, 3 month and 6 month post-op visits)
研究者
Marlene Moster, MD
Attending Surgeon Wills Eye Institute; Professor Jefferson Medical College
Wills Eye