COMPARISON OF EFFECT OF 0.1% VERSUS 0.3% NEPAFENAC ON CHANGES IN MACULAR AND CHOROIDAL THICKNESS AFTER CATARACT SURGERY IN PATIENTS WITH DIABETES MELLITUS.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare the effect of 0.1% versus 0.3% Nepafenac in changes in macular thickness after cataract surgery in diabetes patients.
研究概览
简要总结
Pseudophakic cystoid macular edema (PCME) is one of the common complication following catarct surgery with incidence asa high as 18%.
The emergence of OCT has provided a quick and non invasive means of diagnosis of PCME.
To prevent the production of prostaglandins and decrease the inflammatory effects, we routinely use NSAID’’s in the post operative period.
There are many studies , suggesting the effect of 0.1% nepafenac and 0.3% separately in the prevention of PCME.But there are no studies comparing 0.1% and 0.3 % nepafenac in the prevention of PCME.
Hence the purpose of my study is to compare the effect of 0.1% versus 0.3% nepafenac in the prevention of pseudophakic cystoid macular edema by measuring macular and choroidal thickness by means of OCT and assessing the visual outcome after cataract surgery in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with type 2 diabetes mellitus undergoing cataract surgery All patients of age ranging from 40 – 70 years Patients with Uneventful cataract surgery with intraocular lens ( IOL) in bag Image quality > 40 Patients who are willing for follow up.
排除标准
- •Patients diagnosed with Complicated cataract Mature cataract Uveitic cataract Macular edema at baseline Glaucoma associated with cataract Posterior capsular defect Intraocular lens in sulcus.
- •Patients on treatment for macular edema in the past 3 months.
- •Patients on anti -glaucoma drugs.
- •Cases with unusual post-op inflammation.
- •Other retinal pathologies requiring treatment / compromising vision.
- •Deviation from the specified technique of surgery.
- •Cases requiring YAG capsulotomy within the follow up period.
- •Patients not willing for follow up according to fixed schedule.
- •Cases who require laser photocoagulation in last 3 months.
结局指标
主要结局
To compare the effect of 0.1% versus 0.3% Nepafenac in changes in macular thickness after cataract surgery in diabetes patients.
时间窗: preoperatively and postoperatively at 1 week,1 month and 3 months.
次要结局
- To compare the effect of 0.1% versus 0.3% Nepafenac in changes in choroidal thickness after cataract surgery in diabetes patients(To compare the visual outcome following cataract surgery in diabetic patients.)