CTRI/2021/11/037890已完成4 期
An Open label, single arm, multi centre, Phase IV clinical study to evaluate efficacy and safety of Tropicamide0.2mg/ml, Phenylephrine HCl 3.1mg/ml, Lidocaine HCl 10mg/ml intracameral injection in patientsundergoing cataract surgery.
Sunways India Pvt Ltd6 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2021年12月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 6
- 主要终点
- Pupil size
研究概览
简要总结
It is an Open-label, single-arm, Phase IV clinical study to evaluate the efficacy and safety of Tropicamide 0.2mg/ml, Phenylephrine HCl 3.1mg/ml, Lidocaine HCl 10mg/ml intracameral injection in patients undergoing cataract surgery.
Cataract surgery, also called lens replacement surgery, is the removal of the natural lens of the eye that has developed an opacification, which is referred to as a cataract, and its replacement with an intraocular lens.
Intracameral (IC) administration of mydriatics is an alternative to the traditional topical regimen for cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Signed informed consent prior to any study-mandated procedure.
- •2.Male or female aged 18 years and 65 years (both inclusive).
- •3.Cataract of any grade and type requiring cataract surgery indiscretion of Study Investigator.
- •4.No secondary procedure planned (i.e. trabeculectomy,keratectomy,corneal transplant,vitreoretinal procedure etc.) 5.Systemic condition capable of undergoing topical anesthesia 6.No previous intraocular surgery.
排除标准
- •1.Any iris pathology including but not limited to posterior synechia,iridocorneal endothelial syndrome,corectopia,traumatic mydriasis,Horners syndrome,Adies pupil,cyclodialysis,iridodialysis 2.Corneal pathology affecting pupil magnification or measurement (keratoconus, peripheral thinning,sclerocornea,scarring) 3.Known hypersensitivity to any of the individual formulation of Investigational product.
- •4.Uncontrolled Hypertension as judged by investigator 5.Pregnant and/ or Lactating women.
结局指标
主要结局
Pupil size
时间窗: Time Frame: At beginning, post Investigational product administration, every 5 | minutes till next 30 minutes and completion of cataract surgery
次要结局
- 1.Intraoperative pain(2.Assessment of Clinical Global Impression scale change from baseline)
研究者
研究点 (6)
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