Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
研究概览
简要总结
The purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
详细描述
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •regardless of diabetes duration and retinopathy severity level
- •one or both eyes with focal clinically significant macular edema
- •treated with selective or focal photocoagulation
- •visual capacity under subjective refraction before treatment
- •adequate quality 6mm fast macular map on the day of photocoagulation
- •signed of inform consent
排除标准
- •ocular surgery in the last 4 months
- •previous selective photocoagulation
- •topic or systemic antiinflammatory therapy in the last week
- •allergic to antiinflammatory non-steroids therapy
- •lent contact used in tha last 2 days before photocoagulation
- •history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months
- •history of uveitis or ocular inflammation in the last 12 months
- •any ocular external disease, infection or inflammatory process during evaluation
- •corneal abnormalities that could modify visual capacity per se
- •actual corneal disease
- •pregnancy
- •myopia over -6.00 diopters
- •any retinal disease different from diabetic retinopathy
- •adverse event of the drug
- •desert to pharmacology therapy after the second visit
- •no assistance after the second visit
- •inadequate quality 6mm fast macular map after the second visit
研究组 & 干预措施
Ketorolac
ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation
干预措施: Ketorolac (Drug)
Nepafenac
ocular topic nepafenac 3 times a day during one week after selective photocoagulation
干预措施: Nepafenac (Drug)
Polietilenglicol 400, propilenglicol
ocular lubricant drops 3 times a day for a week after selective photocoagulation
干预措施: Polietilenglicol 400, propilenglicol (Drug)
结局指标
主要结局
ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
时间窗: one week after treatment
次要结局
- visual capacity under subjective refractive correction measured in decimal equivalent(before treatment, at 24, 48, 168 hours after treatment)
- center point thickness using stratus OCT measured in microns(before treatment, at 24, 48 and 168 hours after treatment)
- macular volume using stratus OCT measured in cubic millimeters(before treatment, 24, 48 and 168 hours after treatment)
研究者
Virgilio Lima Gomez
PhD
Hospital Juarez de Mexico