Assessment of Toric IOL Rotational stability between three Toric IOLs
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1. To analyse and compare the rotational stability of three toric IOL’S- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson).
研究概览
简要总结
MATERIALS AND METHODS:
This prospective, interventional, single centre study will be approved by the institutional ethics committee of Nethradhama Super Speciality Eye Hospital and will adhere to the tenets of declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.
PREOP VISIT
Subjects will provide demographic information and medical history and will undergo the following visits at preoperative visit.
· Visual acuity testing
· Refraction
· Slit lamp examination
· IOP evaluation using NCT
· Dilated fundus examination
· Biometry using IOL Master 700
IOL power is calculated using Barrett TK Toric formula. All the eyes will be targeted for emmetropia.
· Corneal topography – Pentacam (Oculus) – to rule out irregular astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Unilateral implant; Eyes with grade 1-4 nuclear sclerosis, cortical cataracts, posterior subcapsular cataract Eyes with regular corneal astigmatism 0.75-5D In the bag IOL implantation.
排除标准
- •Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts Post refractive surgery, History of any previous ocular surgery Complicated cataract Glaucoma, posterior segment pathology retinopathy History of uveitis.
结局指标
主要结局
1. To analyse and compare the rotational stability of three toric IOL’S- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson).
时间窗: performed for 1 day, 2 weeks, and 3 months after surgery.
次要结局
- 2. To assess visual acuity between three toric IOLs’- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson).(performed for 1 day, 2 weeks, and 3 months after surgery.)
研究者
Dr Sri Ganesh
Nethradhama superspeciality eye hospital