Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Changes in Central Subfield Thickness After Cataract Surgery
研究概览
简要总结
This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.
详细描述
Cystoid macular edema remains one of the most important causes of suboptimal visual outcomes after cataract surgery. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce postoperative inflammation and the risk of macular thickening; however, the optimal NSAID regimen remains uncertain.
This prospective randomized clinical study was designed to compare the effectiveness of different postoperative NSAID regimens following uncomplicated phacoemulsification cataract surgery. Eligible patients scheduled for elective cataract surgery were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure. Participants underwent ophthalmic examinations before surgery and at 6 and 12 weeks after surgery.
The primary objective was to evaluate changes in central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT). Secondary assessments included best-corrected distance visual acuity, refraction, and intraocular pressure. All participants received standard perioperative care, and postoperative treatment was administered according to the assigned study regimen.
The study was approved by the Bioethics Committee of the Pomeranian Medical University in Szczecin, and all participants provided written informed consent before enrollment.
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
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
- •Ability and willingness to provide written informed consent.
- •No abnormalities detected on preoperative anterior segment examination.
- •No abnormalities detected on preoperative posterior segment examination.
- •Willingness and ability to attend follow-up visits at 6 and 12 weeks after cataract surgery.
排除标准
- •The exclusion criteria for the study were:
- •Systemic diseases that could affect the macula (e.g. diabetes).
- •Topical or systemic medications that could affect the macula, e.g. chloroquine.
- •Intraoperative complications.
- •Coexisting ocular diseases.
- •Previous ocular surgery.
- •Patients who. for various reasons. declared unwillingness to attend follow-up visits 6 and 12 weeks after cataract surgery.
结局指标
主要结局
Changes in Central Subfield Thickness After Cataract Surgery
时间窗: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), to compare postoperative macular thickness among treatment groups receiving different topical nonsteroidal anti-inflammatory drug (NSAID) regimens following uncomplicated cataract surgery.
次要结局
- Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity(6 weeks and 12 weeks after cataract surgery compare to baseline)
- Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group(6 weeks and 12 weeks after cataract surgery)
- Change in Central Subfield Thickness From Baseline(Baseline, 6 weeks, and 12 weeks after cataract surgery)