ACTRN12612000849897尚未招募未知
Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over a 7 year period.
Brien Holden Vision Institute0 个研究点目标入组 14 人开始时间: 2012年8月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
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-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 15 Years 至 23 Years(—)
- 性别
- All
入选标准
- •have successfully completed IER2008-001
- •be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent (or their parent(s)/legal guardian);
- •if under 18 years of age, must be accompanied by their parent(s)/legal guardian when signing the informed consent form;
- •be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
- •have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses;
- •have vision correctable to at least 6/9 (20/30) or better in each eye with contact lenses;
排除标准
- •an ocular condition that may preclude safe wearing of contact lenses;
- •an active corneal infection or any active ocular disease that would affect wearing of contact lenses;
- •a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
- •any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants;
- •any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology or the performance of the lenses;
- •had eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •undergone corneal refractive surgery;
- •any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
- •contraindications to contact lens wear;
- •had orthokeratology;
- •binocular vision problems such as strabismus or amblyopia;
- •any participant from anti myopia studies who has any unresolved ocular problem
- •currently enrolled in another clinical trial
研究者
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