NCT04392024已完成不适用
Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Uncorrected distant visual acuity
研究概览
简要总结
Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Age-related cataract
- •A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
- •A patient want presbyopia correction at the same time as cataract surgery
- •A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- •Written informed consent to surgery and participation in the study
排除标准
- •Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
- •Pregnant woman and lactating woman
- •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
- •If expectations for presbyopia correction are too high
- •Those who are not able to read and understand the informed consent (illiterate or foreigners)
研究组 & 干预措施
Triumf
Other
Subjects who have cataract surgery with Triumf IOL
干预措施: Triumf (Device)
结局指标
主要结局
Uncorrected distant visual acuity
时间窗: 3 months
Visual acuity at distant with bare eyes
Uncorrected near visual acuity
时间窗: 3 months
Visual acuity at near with bare eyes
次要结局
- Contrast sensitivity(3 months)
- Quality of Vision(3 months)
研究者
tae-young chung
Professor
Samsung Medical Center
研究点 (1)
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