A Randomized Clinical Three-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Preoperative and Postoperative Topical NSAIDs to Only Postoperative Topical NSAIDs to Postoperative Topical NSAIDs and Steroids in Patients Undergoing Cataract Surgery (Pre-CIN).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Central macular thickness after 6 weeks
研究概览
简要总结
The pre-CIN trial is a randomized clinical three-arm trial comparing inflammation and cystoid macular edema for the medication regimens preoperative and postoperative topical NSAIDs to only postoperative topical NSAIDs to postoperative topical NSAIDs and steroids in patients undergoing 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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
- •Scheduled for standard phacoemulsification cataract surgery (group 1 - 3)
- •Scheduled for combined phacoemulsification cataract surgery and MIGS stent (group 4)
- •Ability to cooperate fairly well during the examinations
- •Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.
排除标准
- •Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
- •Pregnancy
- •Mature cataract
- •Active or chronic uveitis with recommendation for steroid treatment
- •Previous trabeculectomy
- •Other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 - 3)
- •Cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation)
- •Patients with complications or other complicating factors during surgery that causes the surgeon to demand both NSAIDs and steroid treatment will be excluded from the main analysis. These patients will be followed postoperatively as part of the study and included in additional analyses (for example as part of an intention to treat analysis).
- •For patients scheduled for cataract surgery in both eyes, only the first operated eye will be included, however, both eyes will be examined.
研究组 & 干预措施
Group 1 NSAIDs pre
Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery
干预措施: Nepafenac Ophthalmic (Drug)
Group 2 NSAIDs post
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
干预措施: Nepafenac Ophthalmic (Drug)
Group 3 NSAIDs and steroids
Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery
干预措施: Nepafenac Ophthalmic (Drug)
Group 3 NSAIDs and steroids
Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery
干预措施: Dexamethasone Ophthalmic (Drug)
结局指标
主要结局
Central macular thickness after 6 weeks
时间窗: 6 weeks after surgery
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 6 weeks
时间窗: 6 weeks after surgery
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
次要结局
- Intraocular inflammation(Preoperatively, and 1 week, 6 weeks, 6 months after surgery)
- Visual outcome(Preoperatively, and 1 week, 6 weeks, 6 months after surgery)
- Intraocular pressure(Preoperatively, and 1 week, 6 weeks, 6 months after surgery)
- Central macular thickness (CMT)(Preoperatively, 1 week, and 6 months after surgery)
- Cystoid macular edema (CME)(Preoperatively, 1 week, and 6 months after surgery)
研究者
Olav Kristianslund
Principal investigator, Head of section / Senior consultant MD PhD
Oslo University Hospital