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临床试验/NL-OMON22813
NL-OMON22813尚未招募不适用

Straylight after Cataract Surgery with Implantation of a Clareon or a Vivinex Monofocal Intraocular Lens

Coöperatie Medisch Specialistisch Bedrijf Amphia U.A.0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Diagnosis of cataract in both eyes,
  • Having consented to and is planned to undergo cataract surgery in both eyes,
  • Planned for implantation of a non-toric monofocal IOL,
  • A targeted refractive error of emmetropia,
  • Age of at least 18 years,
  • Willing and able to participate in both preoperative and postoperative examinations, and
  • Agreeing to sign the informed consent form.

排除标准

  • Insufficient understanding of the Dutch language to comply with study procedures,
  • Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, glaucoma, diabetic eye disease, ocular surface disease, corneal dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
  • Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
  • Subjects with an increased risk of complicated cataract surgery:
  • oLens subluxation or (phaco)iridodonesis,
  • oCataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract,
  • oHistory of ocular trauma
  • Unability to be (reliably) measured with the C-Quant straylight meter, IOLMaster 700, and/or Pentacam,
  • Unability to be (reliably) photographed with slit lamp photography,
  • Corneal astigmatism of =3 diopters,
  • A calculated IOL power for emmetropia in any eye that is outside the available range (i.e., Clareon IOL <6 D or >30 D and Vivinex XY1 IOL <6 D or >30 D).

研究者

发起方
Coöperatie Medisch Specialistisch Bedrijf Amphia U.A.

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