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临床试验/NCT04655274
NCT04655274已完成不适用

Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses

Akdeniz University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
The Quality of Vision score

研究概览

简要总结

The purpose of the present study was to compare the clinical outcomes such as visual function, refraction errors and visual quality of patients undergoing cataract surgery with implantation of two different models of diffractive trifocal IOLs: RayOne Trifocal (Rayner IOL, Ltd.) and AcrySof IQ PanOptix (Alcon Laboratories, Inc.) IOL.

详细描述

Cataract is affecting over 95 million people worldwide and remains the leading cause of vision impairment and blindness. Cataract surgery is an effective method for restoring visual acuity (VA). With the advancement of cataract surgery technique and intraocular lenses (IOL) technologies, expectations of patients from cataract surgery have good vision at distance and near ranges without using spectacles. The standard IOLs design were monofocal, which offered only fixed focal distance. One of the main factors for dissatisfaction after monofocal pseudophakic eyes is lack of accommodation. Previous studies demonstrated that this problem can be resolved by using diffractive trifocal IOLs. Diffractive trifocal IOLs provide effective near, intermediate and distance visual restoration, and has been widely used in patients who want to achieve spectacle independence after surgery. However, some possible optical side effects of trifocal IOLs have been reported, including halos and other dysphotopsias, reduced contrast sensitivity (CS), glare disability, which can significantly affect visual quality and patient satisfaction. The purpose of the present study was to compare the clinical outcomes such as visual function, refraction errors and visual quality of patients undergoing cataract surgery with implantation of two different models of diffractive trifocal IOLs: RayOne Trifocal (Rayner IOL, Ltd.) and AcrySof IQ PanOptix (Alcon Laboratories, Inc.) IOL.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients underwent cataract surgery with trifocal intraocular lenses implantation in one or both eyes

排除标准

  • Amblyopia
  • Axial length (AL) over 25 mm
  • Previous history of corneal or refractive surgery
  • Ocular comorbidity (corneal scars, keratoconus, and corneal endothelial dystrophy, chronic or recurrent uveitis, macular degeneration, diabetes mellitus with retinal changes, glaucoma or intraocular pressure equal or higher than 24 mmHg)
  • Patient inability to understand and/or fill in patient questionnaires

结局指标

主要结局

The Quality of Vision score

时间窗: 3 months

Glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aslı Çetinkaya Yaprak

Principal Investigator

Akdeniz University

研究点 (1)

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