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
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