Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Incision enlargement in mm
研究概览
简要总结
This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors :
Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.
详细描述
In this randomized, clinical trial, three types of injectors were compared :
- Manual, screw type injector (Monarch III)
- Manual, plunger type injector (Royale, ASICO)
- Motorized injector (Autosert, Alcon)
Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion.
The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied.
further, the surgeon was asked to subjectively grade the ease of implantation with each injector
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
- •Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)
排除标准
- •Glaucoma,
- •shallow anterior chamber (depth <2.1mm),
- •prior ocular trauma or surgery,
- •maximal pupillary dilatation <6mm,
- •high myopia (axial length >25mm),
- •posterior polar cataracts,
- •dense cataracts, and
- •an IOL power <19.0 D or >25.0 D
结局指标
主要结局
Incision enlargement in mm
时间窗: 1 minute after surgery
次要结局
- Trypan Blue ingress into the anterior chamber in log units(1 minute after surgery)
- Incision morphology - qualitative(1 day, 1 week and 1 month after surgery)
研究者
Abhay R. Vasavada
M.S., F.R.C.S (England)
Iladevi Cataract and IOL Research Center