The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
研究概览
简要总结
OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution).
DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial.
PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31).
INTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.
Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).
Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).
Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pseudoexfoliation syndrome
排除标准
- •history of ocular inflammation or trauma
- •previous intraocular surgery
- •corneal haze
- •retinal vascular disease
- •diabetic retinopathy
- •variation of the foveal profile at OCT (macular edema, epiretinal membrane)
- •moderate to severe age related macular degeneration
研究组 & 干预措施
Dexamethasone+Tobramycin eye drop
An antibiotic and steroid eye drop association will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week, to 31 patients.
干预措施: Dexamethasone+Tobramycin eye drop (Drug)
Bromfenac
Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients.
干预措施: Dexamethasone+Tobramycin eye drop (Drug)
Bromfenac
Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients.
干预措施: Bromfenac eye drop (Drug)
结局指标
主要结局
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
时间窗: Baseline, Day 3
Reduction of 30% of anterior chamber inflammation evaluated by Laser Flare Photometry (LFP) in the bromfenac arm when compared to the non-bromfenac arm at postoperative day 3.
次要结局
- Proportion of patients who had no ocular pain(Baseline, Day 3)
- Proportion of patients with central macular thickness greater than 300 microns(Baseline, Week 4)
- Proportion of subjects with best corrected visual acuity equal to 20/20(Baseline, Week 1)