Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)
研究概览
简要总结
Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery
Participants: Patients having cataract surgery at UNC who meet eligibility criteria
Procedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.
详细描述
We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both eyes. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. Pre-operatively, all cataracts will be graded using the LOCS III classification system.10 Group 1 will receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation which is standard care for cataract surgery. Following surgery Group 1 will be treated with standard post operative cataract treatment, including a topical antibiotic and a topical corticosteroid. Group 2 will also receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation. Following surgery patients in Group 2 will be treated with topical nepafenac, a topical antibiotic, and a topical corticosteroid. Group 2 will be given the 3ml bottle of nepafenac to take home and instructed to use it three times per day for one month. Intra-operative surgical parameters including ultrasound time and average percent phacoemulsification power will be recorded for all surgeries. All patients will be seen on post-operative day one, one week, one month, and two months. At the two month visit, best corrected ETDRS vision and OCT will be repeated in both eyes. The two month visual acuity and post-operative OCT will be analyzed to evaluate the effect of nepafenac on CME following cataract surgery. Wilcoxon signed rank test will be used to compare pre-operative and post-operative differences between visual acuity and OCT measurements. The Spearman correlation will be used to compare the variables in the study including cataract density, ultrasound time, average percent phacoemulsification power, and OCT measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over age 50
- •having cataract surgery at UNC
排除标准
- •medically controlled diabetes
- •history of intraocular surgery
- •abnormal pre-op optical coherence tomography scan
- •history of ocular inflammation
- •have age related macular degeneration
研究组 & 干预措施
Standard Treatment
topical antibiotic for 10 days and a topical corticosteroid for 1 month
干预措施: Standard Care (Drug)
Nepafenac
1 drop per study eye three times per day for 30 days in addition to standard care
干预措施: nepafenac (Drug)
结局指标
主要结局
Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)
时间窗: baseline and 8 weeks
The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)
Pre-operative Best Corrected Visual Acuity (BCVA)
时间窗: baseline
Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.
Foveal Thickness
时间窗: baseline and 8 weeks
difference in mean pre-post changes by the two treatment groups
Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)
时间窗: baseline and 8 weeks
Post-operative Best Corrected Visual Acuity (BCVA)
时间窗: baseline and 8 weeks
The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.
次要结局
未报告次要终点