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临床试验/NCT04465279
NCT04465279已完成2 期

Evaluation of Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Alexandria University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年10月15日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Visual Acuity

研究概览

简要总结

Multifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

详细描述

Monofocal IOLs, which provide effective distance vision, currently account for the majority of IOLs implantations. Patients who have undergone cataract surgery with implantation of monofocal IOL may require spectacles to perform near-distance (e.g., reading) or intermediate-distance (e.g., using a computer) tasks depending on their visual demandsMultifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation.

排除标准

  • •Any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and Marfan's syndrome).

研究组 & 干预措施

Trifocal Diffractive Intraocular Lens (FineVision)

Experimental

36 eyes having implantation of trifocal diffractive IOL (FineVision)

干预措施: Trifocal diffractive intraocular lens (Device)

结局指标

主要结局

Visual Acuity

时间窗: 3 months

Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision

Defocus curve

时间窗: 3 months

examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame

次要结局

  • Contrast sensitivity(3 months)
  • Visual Satisfaction Questionnaire(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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