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临床试验/JPRN-jRCTs032200118
JPRN-jRCTs032200118已完成未知

Evaluation of performance of Extended Depth of Focus (EDOF) soft contact lens for intraocular lens implanted eyes - EDOF SCL for IOL implanted eyes

Takahiro Hiraoka0 个研究点目标入组 17 人开始时间: 2020年9月14日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
17

研究概览

简要总结

The EDOF contact lens demonstrated better binocular visual acuity at intermediate and near distances but the far visual acuity was slightly affected. Regarding contrast sensitivity, the EDOF contact lens was generally worse than the single vision contact lens from middle to high spatial frequencies, but there was no difference at low spatial frequency (1.5cpd). Near stereopsis was significantly better in EDOF than single vision contact lens.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 <= 75age old(—)
性别
All

入选标准

  • Men and women who understand the contents of the consent explanation document and their informed consents can be obtained.
  • -Those whose ages are between 20 and 75
  • -Those who had undergone cataract surgery 1 month ago or before
  • -Those who have monofocal or toric intraocular lenses inserted in both eyes
  • -Those have spherical equivalent from 0.00 to -6.00D by refraction test
  • -Those who require near or far vision correction
  • -Those who have a total astigmatism of 1.00D or less in both eyes by refraction test
  • -Those who have corrected distance vision in both eyes of 0.7 or better (decimal visual acuity)

排除标准

  • - Patients with moderate or severe grade of corneal/conjunctival or eyelid abnormalities
  • - Patients with uveitis
  • - Patients with dry eye and lacrimal disease that are problematic for lens wear
  • - Patients with allergic diseases that can affect lens wear
  • - Patients with diabetics
  • - Patients with a history of anaphylaxis
  • - Patients with serious cardiac, hepatic, renal, pulmonary, hematological disorders and other complications that are considered inappropriate for the study.
  • - Patients who have participated in other trials within the last 3 months
  • - Pregnant women, women who are breastfeeding or plan to become pregnant during the study
  • - Patients who used hard contact lens (including Orthokeratology lens) within the last 1 month
  • - Patients who wear contact lenses in 1 eye only.
  • - Patients who are judged to be ineligible for the study by the investigators and those are considered unsuitable for wearing soft contact lenses by the investigators.

研究者

发起方
Takahiro Hiraoka

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