CTRI/2025/04/084360尚未招募4 期
Effect of temperature on Intraocular lens unfolding time in cataract surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- To assessand compare unfolding time of various IOL when preheated with hot air oven versus those at room temperature.
研究概览
简要总结
METHODOLOGY:
This prospective, interventional, single center study will be approved by theinstitutional ethics committee of Nethradhama Super Speciality Eye Hospital andwill adhere to the tenets of declaration of Helsinki. Verbal and written informedconsent will be obtained from all patients participating in the study
Primary Objective:
To assess and compare unfolding time of various IOL when preheated with hot air oven versus those at room temperature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts,Posterior subcapsular cataract (LOCS 3 grading) IOL power between +10D to +30D In the bag IOL implantation Hydrophobic acrylic IOL – Johnson & Johnson IOL – Synergy, Puresee, Eyehance, Tecnis, Sensar.
排除标准
- •Hypermature/morgagnian/intumescent and brunescent cataracts more than NS 4
- •Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts less than 1500cells/ mm2
- •Small pupil less than 6mm, Intraoperative floppy iris sydnrome
- •History of glaucoma or intraocular inflammation
- •Macular disease or retinopathy, neuro-ophthalmic diseases, active infections,previous ocular surgery of any kind, any other ocular pathology.
- •Zonular dehiscence or weakness.
结局指标
主要结局
To assessand compare unfolding time of various IOL when preheated with hot air oven versus those at room temperature.
时间窗: post op follow up 1 day,15 and 3 months
次要结局
- To assess and compare total surgical time and to assess the outcome between 2 groups(post op follow up 1 day,15 and 3 months)
研究者
研究点 (1)
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