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临床试验/CTRI/2020/08/027105
CTRI/2020/08/027105已完成未知

Clinical outcomes and quality of vision following bilateral implantation of a newExtended Depth of Focus (EDoF) Intraocular Lens - EDoF

Dr Sri Ganesh0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
30

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

  • A patient with cataract for which phacoemulsification or femtolaser assisted cataract surgery with
  • posterior chamber IOL implantation
  • · Male or female in good general health, 40-80 years of age at the time of the pre-operative
  • examination
  • · A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL
  • implantation
  • · A patient with preoperative corneal astigmatism less than 1D and stable corneal conditions within
  • the last 12 months
  • · A patient with clear ocular media other than cataract in each eye
  • · A patient with normal OCT of the macula in each eye

排除标准

  • A patient with a known pathology that may affect visual acuity (as determined by the Investigator);
  • particularly retinal changes that affect vision (macular degeneration, cystoid macular edema,
  • proliferative diabetic retinopathy, etc.) in either eye
  • A patient with amblyopia or strabismus
  • A patient with capsule or zonular abnormalities that may affect postoperative centration or tilt of the
  • lens (e.g. pseudoexfoliation syndrome) in either eye
  • A patient has a history of significant ocular trauma or prior ocular surgery in either eye
  • A patient with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism (e.g.
  • Keratoconus)
  • A patient that may or is expected to undergo surgical intervention and/or ocular laser treatment prior
  • to or during the study period in either eye
  • Need for a dioptre out of the range of +16.0D to +26.0D
  • A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic
  • disease is not yet stabilized will not be considered for entry into the study
  • A patient currently participating or has participated within 30 days prior to the start of this study in a
  • drug or other investigational research study

研究者

发起方
Dr Sri Ganesh

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