Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative pupil diameter
研究概览
简要总结
Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.
详细描述
The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Preoperative and postoperative assessment will be done by a masked observer.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases of bilateral visually significant cataract
排除标准
- •Poor pupil dilation(less than 6 mm diameter).
- •History of previous eye surgery or trauma
- •History of use of eye drops affecting pupil size such as pilocarpine.
- •Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine.
- •Pediatric age group (less than 18 years old).
- •Pupil abnormalities, such as anisocoria or neurological disorders.
- •Associated glaucoma, uveitis, corneal, retinal or optic nerve disease.
- •Cases scheduled for phacoemulsification under general anaesthesia (to exclude possible ocular and systemic effects or interactions of anaesthetic agents).
- •Patients with bleeding tendency or on anti-coagulant therapy (because peribulbar and subconjunctival injections are used).
研究组 & 干预措施
Atropine sulfate and Epinephrine
Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).
干预措施: Atropine sulfate and epinephrine (Drug)
Topical cyclopentolate and phenylephrine
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
干预措施: Topical cyclopentolate and phenylephrine (Drug)
结局指标
主要结局
Intraoperative pupil diameter
时间窗: 1 day
Intraoperative pupil diameter measurements of involved eye in mm
次要结局
- Postoperative complications(Starting from first postoperative day till one month.)
- Postoperative corneal thickness(1 month after surgery)
- Postoperative corneal endothelial density(1 month after surgery)
- Postoperative pupil diameter(one day, one week and one month after surgery)
- Postoperative visual acuity(One day, one week and one month after surgery)
- Postoperative intraocular pressure (IOP)(One day, one week and one month after surgery)
研究者
Dr. Ashraf Nossair, MD
Associate Professor of Ophthalmology, Cairo University
Dar El Oyoun Hospital