Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- pupil dilating
研究概览
简要总结
The primary aim of the study is to compare the effectiveness of the intracameral application of Mydrane® (standardized combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1%) with the preoperative topical application (Tropicamide 0.5% and Phenylephrine 10%). To evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the age of 50 to 100 years
- •Day-hospital and inpatient care
- •Clinically significant opacity of the lens with indication for cataract surgery on both eyes
- •Lack of previous ophthalmic surgeries
- •Lack of relevant ophthalmic conditions: Pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine HCL 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis
排除标准
- •Allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate
- •Allergic to anesthesia (amide type)
- •Allergic to atropine derivates
- •Heart disease, tachycardia, hypertensive crises
- •Aneurism of big vessels
- •Untreated hyperthyroidism
- •Untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs
- •Pregnancy, breast feeding and premenopausal women
研究组 & 干预措施
Standard eye Drops
Phenylephrine 10% and Tropicamid 0,5% eye drops
干预措施: eye drops (Phenylephrin) (Drug)
injection solution
Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution
干预措施: Eye injection (Mydrane) (Drug)
Standard eye Drops
Phenylephrine 10% and Tropicamid 0,5% eye drops
干预措施: eye drops (Tropicamid) (Drug)
结局指标
主要结局
pupil dilating
时间窗: during first and second surgery: a maximum of four weeks between first and second surgery
The frequency of the feasibility of capsulorhexis without additional pupil dilating actions
次要结局
- subjective highest intraoperative pain(after first and second surgery: a maximum of four weeks between first and second surgery)
- subjective perception of anesthetic procedures(after first and second surgery: a maximum of four weeks between first and second surgery)