ISRCTN28719734已完成未知
MiSIght effect of uncorrected astigmatism on visual acuity non-dispensing study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- 性别
- All
入选标准
- •1. Age 8 to 16 years
- •2. Current soft contact lens wearers
- •3. Spectacle refraction: -0.75 to -6.00 D spherical equivalent, with cylinder of -0.50 DC to -1.75 DC
- •4. Best corrected visual acuity of at least 20/25 in each eye
- •5. Have normal eyes with the exception of the need for visual correction
- •6. Parent/guardian and participant have read and understood the Participant Information Sheet
- •7. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable)
排除标准
- •To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
- •The following are specific criteria that exclude a candidate from enrolment in this study:
- •1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- •2. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
- •3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
- •4. Subjects with slit lamp findings greater than grade 2 or higher (e.g. oedema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit
- •5. History of herpetic keratitis, ocular surgery or irregular cornea
- •6. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
研究者
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