NCT01395069已完成4 期
Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in macular volume (as quantified by OCT) at one month (compared to baseline)
研究概览
简要总结
Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •Age 18 years and older
排除标准
- •Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
- •Previous uveitis
- •Previous intraocular surgery
- •Allergy or hypersensitivity to NSAIDs
- •Complicated cataract surgery
研究组 & 干预措施
Nepafenac 0.1%
Active Comparator
干预措施: Nepafenac 0.1% (Drug)
Ketorolac 0.5%
Active Comparator
干预措施: Ketorolac 0.5% (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (sterile saline drops) (Other)
结局指标
主要结局
Change in macular volume (as quantified by OCT) at one month (compared to baseline)
时间窗: baseline and one month after surgery
次要结局
- COMTOL health-related quality-of-life(one month after surgery)
研究者
Dr. Sherif R El-Defrawy
Principal Investigator
Queen's University
研究点 (1)
Loading locations...
相似试验
终止
4 期
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in PrematurityBlindnessRetinopathy of PrematurityRetinal DetachmentNCT00634972University of South Alabama83
Unknown
3 期
Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma DropsMGD-Meibomian Gland DysfunctionDry EyeNCT03515187Shenzhen Hospital of Southern Medical University160
已完成
不适用
Effect of Prophylactic Ketorolac on CME After Cataract SurgeryMacular Edema, CystoidNCT00335439Queen's University98
已完成
不适用
Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive KeratectomyMyopiaNCT01475877Virdi Eye Clinic20
已完成
4 期
Topical Antibiotic Prophylaxis for EyelidsAntibiotic Side EffectEyelid DiseasesSurgical Wound InfectionSurgical Wound, RecentSurgical IncisionSkin Cancer FaceAntibiotic AllergySurgical Site InfectionWound EyelidNCT03199911University of California, San Francisco401