Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Visual acuity(Distant, intermediate, near)
研究概览
简要总结
To assess postsurgical visual acuity (distant, intermediate, near), refractive errors, contrast sensitivity, visual function and patient satisfaction after implantation of multifocal IOLs of different add power contralaterally.
详细描述
Multifocal intraocular lens (MIOL) is considered a prevailing alternative to restore the functional vision from far to near independent of glasses. Many clinical studies on diffractive MIOLs, refractive MIOLs, or hybrid MIOLs in enhancing quality of vision showed promising outcomes. Several studies have confirmed the satisfactory visual outcomes of Tecnis MIOL with +4.00 D add power. The purpose of study is to assess the visual performance after cataract surgery with bilateral implantation of multifocal IOL with two different add power (+2.75 D or +3.25 D) in one patient.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age-related cataract
- •Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye.
- •A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation.
- •A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
- •Written informed consent to surgery and participation in the study
排除标准
- •• Pregnant woman and lactating woman
- •A patient with history of retinal disease
- •A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
- •A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
- •A patient that has been wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended -wear or daily soft contact lens within 7 days of their scheduled surgery.
- •Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract, or marfan syndrome
- •Those who are not able to read and understand the informed consent (illiterate or foreigners)
结局指标
主要结局
Visual acuity(Distant, intermediate, near)
时间窗: 1month
次要结局
- Visual acuity(Distant, intermediate, near)(3month)
研究者
tae-young chung
Professor
Samsung Medical Center