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临床试验/NCT01995630
NCT01995630已完成不适用

Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Distance-corrected intermediate visual acuity

研究概览

简要总结

The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively

排除标准

  • Uveitis, pathology of the retina or the optic nerve
  • Corneal scarring or irregularities
  • Astigmatism >1.5 D
  • Amblyopia
  • Perioperative complications
  • Postoperative refractive error >2.0 D of spherical equivalent
  • Postoperative DCVA <0.8 (ETDRS)

结局指标

主要结局

Distance-corrected intermediate visual acuity

时间窗: 3 month postop

次要结局

  • Pseudoaccomodation(3 month postop)
  • Photopic contrast sensitivity(3 month postop)
  • Distance-corrected near visual acuity(3 month postop)
  • Uncorrected distance visual acuity(3 month postop)
  • Corrected distance visual acuity(3 month postop)
  • Uncorrected near visual acuity(3 month postop)
  • Corrected near visual acuity(3 month postop)
  • Mesopic contrast sensitivity(3 month postop)
  • Spherical aberrations(3 month postop)
  • High order aberrations(3 month postop)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Navid Ardjomand

Univ.-Doz. Dr. med. univ.

Medical University of Graz

研究点 (2)

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