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临床试验/ACTRN12612000849897
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

发起方
Brien Holden Vision Institute

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