A Placebo-controlled, Randomized, Clinical Trial of Prophylactic Ketorolac 0.5% in Patients Undergoing Pars Plana Vitrectomy and Phacovitrectomy Epiretinal Membrane Peel Surgery: Assessing Macular Volume With Spectral-domain OCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in macular volume from baseline.
研究概览
简要总结
Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Since post-intraocular surgery inflammation is a contributing factor to macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the deleterious effects of macular swelling after epiretinal membrane surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic epiretinal membrane diagnosis requiring membrane peel surgery
排除标准
- •proliferative diabetic retinopathy
- •sickle cell retinopathy
- •radiation retinopathy
- •choroidal folds
- •hypersensitivity or allergy to NSAIDs
- •wet macular degeneration
- •branch retinal vein occlusion (BRVO)
- •central retinal vein occlusion (CRVO)
- •complicated membrane peel surgery
研究组 & 干预措施
PPV-MP + Placebo (Saline drops)
PPV-MP= pars plana vitrectomy membrane peel
干预措施: Saline drops (Other)
PPV-MP + Ketorolac 0.5%
PPV-MP= pars plana vitrectomy membrane peel
干预措施: Ketorolac 0.5% (Drug)
PhacoVit-MP + Placebo (Saline drops)
PhacoVit-MP= phacovitrectomy membrane peel
干预措施: Saline drops (Other)
PhacoVit-MP + Ketorolac 0.5%.
PhacoVit-MP= phacovitrectomy membrane peel
干预措施: Ketorolac 0.5% (Drug)
结局指标
主要结局
Change in macular volume from baseline.
时间窗: Before surgery, at 1 week, 1 month, and 1 year after surgery.
次要结局
未报告次要终点