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临床试验/NCT04907955
NCT04907955已完成不适用

Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses

Dar Al Shifa Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
visual acuity

研究概览

简要总结

The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients with normal ocular examination apart from cataract.

排除标准

  • •previous ocular surgery.
  • •ocular pathology or corneal abnormalities.
  • •an endothelial cell count below 2000 cells/mm
  • •corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).

研究组 & 干预措施

panoptix PANFOCAL intraocular lens

Active Comparator

panoptix PANFOCAL intraocular lensis a single-piece aspheric non-apodized diffractive panfocal IOL that distributes light energy to three focal points in both small and large pupil conditions

干预措施: phacoemulsification with implantation of presbyopia correcting IOL (Procedure)

Trifocal Diffractive the AT LISA intraocular lens

Active Comparator

Trifocal Diffractive the AT LISA is a preloaded single-piece aspheric diffractive trifocal IOL and made of hydrophilic acrylic with a hydrophobic surface with an ultraviolet absorber. This aspheric IOL is aberration -correcting in order to reduce and compensate for corneal spherical aberrations.

干预措施: phacoemulsification with implantation of presbyopia correcting IOL (Procedure)

Symphony EDOF (extended depth of focus) intraocular lens

Active Comparator

SYMPHONY EDOF intraocular lens is a single-piece aspheric biconvex hydrophobic acrylic IOL with a 6.0 mm optic and an 13.0 mm overall diameter. This IOL consists of a wavefront-designed anterior aspheric surface (negative spherical aberration of -0.27 mm to counterbalance the net positive spherical aberration from cornea) and a posterior achromatic diffractive surface with echelette design.

干预措施: phacoemulsification with implantation of presbyopia correcting IOL (Procedure)

结局指标

主要结局

visual acuity

时间窗: 6 months postoperatively.

The monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuity (4 m), uncorrected intermediate visual acuity (UIVA) (60 cm and 80 cm), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (40 cm), and distance-corrected near visual acuity (DCNVA) were assessed. Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm.

次要结局

  • contract senstivity(6 months postoperatively.)
  • photic phenomena(6 months postoperatively.)
  • spectacle independence(6 months postoperatively.)
  • defocus curve(6 months postoperatively.)

研究者

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

magda torky

Principle investigator

Dar Al Shifa Hospital

研究点 (1)

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