A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- cystoid macular edema
研究概览
简要总结
The purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.
Patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.
详细描述
Purpose:
To compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.
Methods:
This will be a masked single-center, randomized clinical study comprising 80 patients undergoing phacoemulsification cataract surgery. Patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (CME) risks (diabetic retinopathy, retinal vascular disease or macular abnormality) will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group;n=40) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group;n=40) for three days preoperatively and four weeks postoperatively. In both groups topical gatifloxacin will be administered to the treated eye QID, starting three days before surgery and continuing for seven days. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema. Other included outcomes will be best corrected visual acuity (BCVA), intraocular pressure (IOP), CME incidence, retinal thickness as measured by spectral-domain optical coherence tomography (OCT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with nuclear cataract, density 1 and 2 classified by LOCS II, scheduled to undergo phacoemulsification cataract surgery.
排除标准
- •Patients with:
- •Diabetes,
- •Hypertension,
- •macular disease,
- •congenital ocular abnormalities,
- •cataract density 0 and 3 by LOCS II,
- •pseudoexfoliation syndrome.
- •Patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.
研究组 & 干预措施
ketorolac tromethamine
干预措施: Ketorolac Tromethamine (Drug)
Dextrano 70 / Hypromellose
干预措施: Ketorolac Tromethamine (Drug)
结局指标
主要结局
cystoid macular edema
时间窗: 1 month
Angiography (Miyake's criteria)
次要结局
- Best corrected visual acuity(1 month)
研究者
Joao Paulo Felix
Dr.
University of Campinas, Brazil
