Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- safety of intracameral Fydrane on endothelial cell count
研究概览
简要总结
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.
详细描述
in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medium density cataract (nuclear II to III)
排除标准
- •soft or hard density cataract (nuclear I or IV)
- •history of ocular trauma or previous intraocular surgery
- •iatrogenic, congenital or traumatic cataract
- •associated eye disease e.g. pseudoexofoliation syndrome
- •associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
- •associated systemic disease that can affect endothelium,
结局指标
主要结局
safety of intracameral Fydrane on endothelial cell count
时间窗: 3 weeks postoperative
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative
次要结局
- effect of Fydrane on pupil diameter during phacoemulsification(pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation))