The Effect of Topical Sodium Diclofenac on Macular Thickness in Diabetic Eyes After Phacoemulsification: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- macular thickness changes
研究概览
简要总结
Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.
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, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients with non-proliferative diabetic retinopathy that were candidate for phacoemulsification and intraocular lens implantation
排除标准
- •Eyes with clinically significant macular edema based on the ETDRS(Early Treatment Diabetic Retinopathy Study) study and/or central macular thickness >260µ were not included. Neither did we include the eyes with other accompanying diseases affecting the macula or eyes with history of previous retinal laser photocoagulation or intraocular surgery.
- •Eyes with severe cataract that preclude performing an acceptable quality optical coherence tomography (OCT) were not enrolled either.
研究组 & 干预措施
placebo (ARTIFICIAL TEAR)
control group received artificial tear (Sina Darou Laboratories Company, Tehran, Iran) as a placebo every 6 hours. Theses drops continued up to 6 weeks with the same dose after operations.
干预措施: Prescribe ARTIFICIAL TEAR (Drug)
diclofenac sodium drop
case group received diclofenac sodium drop 0.1% (Sina Darou Laboratories Company, Tehran, Iran) every 6 hours.. Theses drops continued up to 6 weeks with the same dose after operations.
干预措施: Prescribe diclofenac sodium drop 0.1% (Drug)
结局指标
主要结局
macular thickness changes
时间窗: preoperatively until 90 days
Optical coherence tomography (OCT)
次要结局
- best corrected visual acuity (BCVA) changes(preoperatively until 90 days)
研究者
Zahra Rabbani Khah
Clinical Professor, Ophthalmic Research Center
Shahid Beheshti University of Medical Sciences