Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
试验速览
- 阶段
- 4 期
- 发起方
- Aurolab
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- vision improvement
研究概览
简要总结
The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.
详细描述
Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.
Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 65
- •Senile cataract
- •Posterior Sub Capsular Cataract (PSCC)
- •Astigmatism 1.25 D or more
- •Residence within 100 kms of Madurai
排除标准
- •Traumatic & Complicated cataract
- •Poor mydriasis
- •Amblyopia
- •Severe Pseudo exfoliation (PXF)
- •Dense posterior polar cataract (PPC)
- •One eyed patients
- •Corneal pathology / Scar
- •Retinal Pathology contributing to visual loss
- •Intraoperative complication like PC rupture, Zonular dialysis
结局指标
主要结局
vision improvement
时间窗: 150 days
The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively
次要结局
- Refractive error correction(150 days)