跳至主要内容
临床试验/NCT05581888
NCT05581888进行中(未招募)不适用

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

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
62
试验地点
1
主要终点
uncorrected intermediate visual acuity (UIVA)

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 postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.

详细描述

Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • required binocular cataract extraction
  • age > 21 years
  • length of optic axis > 26 mm

排除标准

  • irregular corneal astigmatism > 0.3 um;
  • 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 intermediate visual acuity (UIVA)

时间窗: one year

uncorrected visual acuity at 60 cm

best corrected distance visual acuity (BCVA)

时间窗: one year

corrected visual acuity at 5 m

uncorrected near visual acuity (UNVA)

时间窗: one year

uncorrected visual acuity at 40 cm

uncorrected distance visual acuity (UDVA)

时间窗: one year

uncorrected visual acuity at 5 m

次要结局

  • HOAs(three months)
  • Strehl Ratio(three months)
  • objective visual quality(three months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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