Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- IOP at 6 hours after surgery
研究概览
简要总结
This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery.
Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.
The treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination immediately after surgery, and the control group will receive no treatment. The IOP will be measured preoperatively and at 6, 12, and 24 hours postoperatively.
详细描述
Phacoemulsification with the use of an ophthalmic viscosurgical device (OVD) and implantation of a foldable intraocular lens (IOL) is the preferred technique for cataract surgery today.
OVDs in spite of their advantages in phacoemulsification surgery, have been correlated with intraocular pressure (IOP) increase within the first 24 hours postoperatively. This constitutes a frequent short-term complication of cataract surgery and can lead to corneal edema and pain. This IOP rise may also increase the risk of retinal artery occlusion, ischemic optic neuropathy, and deterioration of preexisting glaucomatous nerve damage.
DuoVisc, an OVD that consists of Viscoat (chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) in combination with Provisc (sodium hyaluronate 1.0%) is the most frequently used OVD during cataract surgery.
To prevent IOP spikes postoperatively, various antiglaucoma agents have been used. Brinzolamide is a carbonic anhydrase inhibitor that acts upon the ciliary processes and reduces aqueous humor secretion.Brimonidine is a highly selective a2-adrenergic agonist that increases uveoscleral outflow and reduces aqueous humor production.
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
- Double (Participant, Investigator)
盲法说明
Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo cataract surgery by phacoemulsification.
排除标准
- •previous ocular surgery
- •ocular hypertension
- •pseudoexfoliation syndrome
- •pigment dispersion syndrome
- •history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
- •hypersensitivity to sulfonamides or brimonidine
研究组 & 干预措施
Brinzolamide-Brimonidine fixed combination
1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery
干预措施: Brinzolamide-Brimonidine fixed combination (Drug)
结局指标
主要结局
IOP at 6 hours after surgery
时间窗: 6 hours postoperatively
IOP will be measured by the same Goldman applanation tonometer used preoperatively
次要结局
- IOP at 12 hours after surgery(12 hours postoperatively)
- IOP at 24 hours after surgery(12 hours postoperatively)
研究者
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
University Hospital of Patras