跳至主要内容
临床试验/jRCTs042210092
jRCTs042210092已完成不适用

Comparison of Silicone Hydrogel Daily Disposable Multifocal Contact Lens (MyDay daily disposable Multifocal) and Habitually Worn Soft Contact Lenses in Presbyopic Patients

未提供0 个研究点目标入组 119 人开始时间: 2021年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomized Controlled Trial
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
42age old over 至 No limit(—)
性别
All

入选标准

  • He/she is at least 42 years of age when giving his/her informed consent
  • He/she is presbyopia
  • He/she habitually wears any of the following SCLs for at least 8 hours a day, 5 days a week until he/she gave consent
  • Daily disposable sphere soft contact lenses (Any brand)
  • Multifocal silicone hydrogel lenses "Dailies Total 1 MF"
  • Multifocal hydrogel lenses "Proclear 1 Day MF"
  • He/she can achieve a corrected distance visual acuity of at least 0.9 (decimal visual acuity) in each eye through refractive correction with spherocylindrical lenses
  • He/she has sphere power of +3.00~-8.00 when taking into account vertex distance
  • He/she has refractive astigmatism (cylindrical power) no higher than 1.00D from a manifest refraction
  • He/she requires a reading addition of at least +0.75D and no more than +2.50D from a manifest refraction
  • He/she is willing to undergo a medical examination on the specified examination date
  • He/she understood the information sheet and was able to give his/her voluntary written consent.

排除标准

  • He/she has worn hard contact lenses within 30 days before giving his/her consent
  • He/she has undergone refractive error surgery
  • He/she who has had an aphakic intraocular or intraocular lens implanted in his/her eye(s)
  • He/she is evaluated by slit lamp to have anterior ocular complications evaluated to be 3 or higher on the Efron Grading Scales
  • He/she is not satisfied with his/her visual quality with a single adjustment to sphere power of study lenses at baseline
  • He/she who has the following ophthalmic diseases
  • Acute and subacute inflammation of the anterior chamber of the eye
  • Ocular infection
  • Decreased corneal sensitivity
  • Eyelid abnormalities
  • He/she who has dry-eye symptoms and lacrimal apparatus disease to an extent that may cause issues in wearing lenses
  • He/she who has allergic diseases that may impact wearing lenses
  • He/she who usually resides in a dry environment
  • He/she who resides in an environment where dust and chemicals, etc. easily enter the eyes
  • He/she who is unable to follow the physician's instructions
  • He/she who is unable to use the lenses in an appropriate manner
  • He/she who is unable to follow lens care regimen
  • She self-reports as pregnant, lactating, or taking oral contraceptives
  • He/she who is participating in other clinical trials or studies
  • Anyone who is determined by the Co-Principal Investigators or others to be ineligible for this study.

结局指标

主要结局

-

Overall satisfaction for study lens

次要结局

未报告次要终点

研究者

发起方
未提供

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