Comparison Between Low-dose and High-dose Nepafenac Sodium in Preventing Macular Edema After Cataract Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Central macular thickness
研究概览
简要总结
In South Punjab, Pakistan, where tertiary hospitals manage a high cataract workload, data on nepafenac sodium to reduce this inflammatory response is not up to the mark. Relative benefit of low-dose versus high-dose regimens remains unclear in routine clinical practice. Therefore, this study was performed with the objective to compare the effectiveness of low-dose nepafenac sodium with high-dose nepafenac sodium in preventing macular edema after cataract surgery.
详细描述
Cataract surgery is among the most commonly performed ophthalmic procedures but postoperative macular edema remains an important cause of delayed or suboptimal visual recovery because surgical inflammation can increase prostaglandin release, disrupt the blood-retinal barrier, and increase central macular thickness. Nepafenac sodium is used to reduce this inflammatory response yet the relative benefit of low-dose versus high-dose regimens remains unclear in routine clinical practice. Comparing low-dose with high-dose nepafenac sodium can therefore clarify whether a lower-dose regimen provides adequate protection with lower cost and treatment burden, or whether high-dose therapy offers superior anatomical and visual benefit after cataract surgery.
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
- None
盲法说明
No masking involved
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 18-60 years
- •Planned for cataract surgery
排除标准
- •Patients with clinical or optical coherence tomography (OCT) evidence of pre-existing macular edema
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Previous stroke
- •Renal failure
- •Ischemic heart disease with unstable symptoms
- •Acute or chronic uveitis
- •Retinitis pigmentosa
- •Diabetic retinopathy
- •Age-related macular degeneration
- •Epiretinal membrane
- •Retinal vein occlusion
- •History of intraocular surgery
- •Traumatic cataract
- •Hypersensitivity to nepafenac or other non-steroidal anti-inflammatory drugs
- •Using topical or systemic anti-inflammatory drugs before surgery
研究组 & 干预措施
High-dose nepafenac sodium
Patients received high-dose nepafenac sodium 0.3% ophthalmic suspension, one drop in the operated eye once daily, starting one day before cataract surgery, continued on the day of surgery, and then continued postoperatively until day 60. An additional drop was instilled 30-120 minutes before surgery.
干预措施: Nepafenac sodium (High-dose ) (Drug)
Low-dose nepafenac sodium
Patients received low-dose nepafenac sodium 0.1% ophthalmic suspension, one drop in the operated eye three times daily, starting one day before cataract surgery, continued on the day of surgery, and then continued postoperatively until day 60. An additional preoperative drop was also instilled 30-120 minutes before surgery.
干预措施: Nepafenac sodium (Low-dose ) (Drug)
结局指标
主要结局
Central macular thickness
时间窗: 60 days after surgery
Reduction in the mean central macular thickness was compared with the baseline to postoperative day 60.
次要结局
- Macular edema index(60 days after surgery)
- Treatment compliance(60 days after surgery)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research