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临床试验/NCT06092164
NCT06092164尚未招募不适用

Visual Outcomes of Different Types of Functional Intraocular Lenses in Cataract Patients

Eye & ENT Hospital of Fudan University0 个研究点目标入组 20,000 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20,000
主要终点
uncorrected distance visual acuity (UDVA)

研究概览

简要总结

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

详细描述

Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses(bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

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

入选标准

  • age > 18 years

排除标准

  • amblyopia; previous ocular surgery;
  • ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
  • requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

结局指标

主要结局

uncorrected distance visual acuity (UDVA)

时间窗: one year

uncorrected visual acuity at 5 m

best corrected distance visual acuity (BCVA)

时间窗: one year

corrected visual acuity at 5 m

uncorrected intermediate visual acuity (UIVA)

时间窗: one year

uncorrected visual acuity at 60 cm

uncorrected near visual acuity (UNVA)

时间窗: one year

uncorrected visual acuity at 40 cm

次要结局

  • Strehl Ratio(three months)
  • contrast sensitivity(three months)
  • visual functions(three months)
  • HOAs(three months)
  • IOL condition(three months)
  • photic phenomena(three years)
  • objective visual quality(three months)
  • subjective satisfaction(three years)

研究者

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

Jin Yang

Professor

Eye & ENT Hospital of Fudan University

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