Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 609
- 试验地点
- 1
- 主要终点
- The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.
详细描述
In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).
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
- 40 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Male or female aged from 40 to 88 years old
- •Scheduled to undergo unilateral cataract surgery
- •Exclusion criteria:
- •Combined surgery
- •Previous intraocular surgery
排除标准
- 未提供
研究组 & 干预措施
T2380
Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.
At the beginning of surgery, 200 μL of T2380 were administrated intracamerally.
干预措施: T2380 (Drug)
T2380
Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.
At the beginning of surgery, 200 μL of T2380 were administrated intracamerally.
干预措施: Tetracaine (Drug)
Mydriatics and anesthetic
Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.
Topical Mydriatic treatments were instilled three times before surgery.
干预措施: Mydriatics (Drug)
Mydriatics and anesthetic
Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.
Topical Mydriatic treatments were instilled three times before surgery.
干预措施: Tetracaine (Drug)
结局指标
主要结局
The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
时间窗: Day 0
次要结局
未报告次要终点