Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- center subfield mean thickness using Stratus OCT measured in microns
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.
详细描述
Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation.
Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •proliferative diabetic retinopathy
- •without macular edema
- •adequate quality 6 mm fast macular map on the day of treatment
- •visual capacity under subjective refraction before treatment
- •signed of inform consent
排除标准
- •ocular surgery in the last 4 months
- •myopia over -6.00 diopters
- •allergy to ketorolac or non-steroids antiinflammatory
- •previous selective photocoagulation
- •using non-steroids antiinflammatory or immunomodulators
- •intraocular inflammatory
- •any retinal disease different from diabetic retinopathy
- •pregnancy
- •actual corneal disease
- •inadequate quality 6 mm fast macular map after the second visit
- •inconsistency after the second visit
- •adverse event of the drug
- •remove of the inform consent
研究组 & 干预措施
Ketorolac tromethamine
ocular topic ketorolac used 4 times a day during a week after panphotocoagulation
干预措施: Ketorolac tromethamine (Drug)
Polivynilic alcohol
ocular lubricant drops 4 times a day during one week after panphotocoagulation
干预措施: Polivynilic alcohol (Drug)
结局指标
主要结局
center subfield mean thickness using Stratus OCT measured in microns
时间窗: baseline, 24, 48 and 168 hours after treatment
次要结局
- center point thickness using Stratus OCT, measured in microns(baseline, 24, 48 and 168 hours after treatment)
- macular volume using Stratus OCT, measured in cubic millimeters(baseline, 24, 48 and 168 hours after treatment)
研究者
Virgilio Lima Gomez
PhD
Hospital Juarez de Mexico