CONTACT LENSES AND MYOPIA (CLAMP) STUDY

隐形眼镜和近视（夹钳）研究

• 批准号: 6125171
• 负责人: JEFFREY JAY WALLINE
• 金额: $ 9.78万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6125171
• 关键词: astigmatism; clinical research; clinical trials; contact lens; data collection methodology /evaluation; eye disorder diagnosis; human subject; longitudinal human study; middle childhood (6-11); myopia; outcomes research; pathologic process; questionnaires; ultrasonography; vision tests

The Contact Lenses and Myopia Progression (CLAMP) Study will serve two purposes: 1) it will provide the training mechanism for Jeffrey J. Walline, O.D. to become a successful independent investigator and 2) it will evaluate the effect of rigid contact lenses on myopia progression in children. The CLAMP Study applies itself very well to furthering Dr. Walline's education and clinical experience. The CLAMP Study will generate the basis for Dr. Walline's qualifying examinations and his doctoral thesis, which will focus on his coursework in Physiological Optics and Preventive Medicine. Dr. Walline will serve as Principal Investigator and will gain valuable experience in all aspects of clinical research. He will be responsible for the recruitment, retention, ocular examination, and contact lens fitting of 110 children, most data collection, all data input and analysis, and the administrative functions of the entire study. The training plan, combined with the wide range of responsibilities in conducting this small-scale study, will produce an independent clinician-scientist who has learned the trials and tribulations of clinical research by direct application of his training and by personal experience. The CLAMP Study will examine the effects of rigid contact lenses on myopia progression in nearsighted children over a three-year period and will attempt to determine the mechanism of treatment effect if one exists. We will conduct a single-masked, randomized clinical trial on 110 children ages 8 to 11 years old who have between -1.00 D and -3.00 D (spherical component) of myopia in each eye, less than 1.00 D of astigmatism in both eyes, less than 1.00 D of anisometropia, no ocular or systemic health problems that may affect vision, and at least 20/20 best corrected visual acuity in both eyes. All subjects will be given a comprehensive baseline examination and fitted with rigid contact lenses; those who meet the minimum requirements for rigid contact lens adaptation will be randomized to the experimental group (rigid contact lenses) or to the control group (soft contact lenses). Annual examinations will be given to all children to determine their myopic progression, and to measure their ocular components. Their vision correction will be updated every six months. The CLAMP Study is the ideal scope and size of study to train Dr. Walline to become an independent investigator and has the potential to change the standard of care for young children who become nearsighted.

隐形眼镜与近视进展(CLAMP)研究将服务于两个 目的：1)为Jeffrey J. 成为一名成功的独立调查员 将评估硬性隐形眼镜对近视进展的影响 在孩子们身上。 钳位研究很好地应用于进一步发展瓦莱尔博士的 教育和临床经验。夹具研究将生成 瓦莱博士资格考试和博士论文的基础， 将专注于他在生理光学和 预防医学。 瓦莱尔博士将担任首席研究员，并将获得宝贵的 有临床研究各方面的经验。他将对此负责 用于招募、保留、视力检查和隐形眼镜 110名儿童的试衣，大部分数据收集，所有数据输入和 分析，并对整个行政职能进行研究。这个 培训计划，结合在 进行这项小规模的研究，将产生一个独立的 临床医生-科学家，他了解了 HIS培训直接应用和个人参与的临床研究 经验。 夹具研究将检查硬性隐形眼镜对 近视儿童近视进展的三年时间和 将尝试确定治疗效果的机制，如果 是存在的。我们将进行一项单盲随机临床试验 110名8至11岁的儿童，-1.00至-3.00 每只眼近视的D(球面成分)，小于1.00D的 双眼散光，屈光参差小于1.00D，无眼部 或可能影响视力的系统性健康问题，至少20/20 双眼最佳矫正视力。所有的科目都会给出 全面的基线检查，并配有刚性接触 镜片.满足硬性隐形眼镜最低要求的镜片 将适应性随机分配到试验组(刚性接触 镜片)或对照组(软性隐形眼镜)。每年一次 将对所有儿童进行检查，以确定他们的近视 进展，并测量他们的眼睛组成部分。他们的愿景 更正将每六个月更新一次。 钳位研究是培养博士的理想研究范围和规模。 瓦莱尔将成为一名独立调查员，并拥有 有可能改变对成为 近视。