Study of the Efficacy of Brinzolamide 1% Plus Brimonidine 0.2% Versus Brimonidine 0.2% in the Prevention of Intraocular Pressure Rise After Nd-YAG Laser Capsulotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
研究概览
简要总结
To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium: yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.
详细描述
In this prospective, randomized, double masked clinical trial, patients scheduled to undergo Nd:YAG laser posterior capsulotomy for posterior capsule opacification are randomized in 3 groups. The Brimonidine group receives 1 drop of Brimonidine 0.2%. The Brinzolamide/Brimonidine group receives 1 drop of Brinzolamide 1%/Brimonidine 0.2% fixed combination. The Control group receives artificial tears. All groups are administered a single drop instillation, approximately one hour before Nd:YAG application. Intraocular pressure measurements are performed before treatment (baseline) and at the 1, 3, 24 hours and 1 week post treatment.
Dexamethasone ophthalmic drops are prescribed q.i.d. for one week after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients are masked to their assignment by covering the labels on the bottles of the drugs administered The investigator responsible for the measurement of the intraocular pressure is also masked to the intervention administered to each patient.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (PCO) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (IOL/PC).
排除标准
- •baseline IOP greater than 21mmHg
- •glaucomatous eyes, already under treatment with anti glaucomatic medications
- •intraocular surgery except for uncomplicated cataract surgery
- •previous photorefractive surgery
- •active ocular inflammation or infection
- •patients under systemic administration of medications known to affect IOP
- •patients with severe respiratory or cardiovascular disease
- •pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested
- •a measurement of IOP > 30 mmHg at any time point of the study, or an increase from baseline >20 mmHg
研究组 & 干预措施
Brinzolamide/Brimonidine FC
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
干预措施: Brinzolamide/Brimonidine FC (Drug)
Brimonidine 0.2%
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
干预措施: Brimonidine 0.2% (Drug)
Artificial tears
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
干预措施: Artificial tears (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
时间窗: 1 hour
Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy
时间窗: 3 hours
Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
时间窗: 24 hours
Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
时间窗: 1 week
Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP
次要结局
未报告次要终点
研究者
Constantinos D. Georgakopoulos, MD, PhD
MD, PhD, Associate Professor of Ophthalmology, Univerisity of Patras
University Hospital of Patras