CONTACT LENSES AND MYOPIA (CLAMP) STUDY

隐形眼镜和近视（夹钳）研究

• 批准号: 2838239
• 负责人: JEFFREY JAY WALLINE
• 金额: $ 9.4万
• 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/2838239
• 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）研究将为两个 目的：1）为Jeffrey J. Waline，O.D.成为一名成功的独立调查员，2）它 将评估硬性角膜接触镜对近视进展的影响 小儿 CLAMP研究很好地促进了瓦林博士的 教育和临床经验。 CLAMP研究将生成 瓦林博士的资格考试和博士论文的基础， 这将集中在他的生理光学课程， 预防医学。 博士沃林将担任首席研究员，并将获得宝贵的 在临床研究的各个方面。 他将负责 用于招募、保留、眼部检查和接触透镜 110名儿童的拟合，大部分数据收集，所有数据输入， 分析，以及整个研究的行政职能。 的 培训计划，结合广泛的责任， 进行这项小规模的研究，将产生一个独立的 临床科学家谁已经学会了考验和磨难， 通过直接应用他的培训和个人 体验. CLAMP研究将检查硬性角膜接触镜对 近视儿童在三年内的近视进展， 将试图确定治疗效果的机制，如果一个 存在. 我们将进行一项单盲随机临床试验， 110名8至11岁的儿童，D在-1.00至-3.00之间 D（球镜分量），每只眼睛的近视小于1.00 D， 双眼散光，屈光参差小于1.00 D，无眼 或可能影响视力的系统性健康问题，并且至少20/20 双眼最佳矫正视力。 所有科目将给予 一个全面的基线检查，并配备了刚性接触 镜片;符合硬性接触透镜最低要求的镜片 适应将被随机分配到实验组（刚性接触 隐形眼镜）或对照组（软性隐形眼镜）。 年度 所有儿童将接受检查，以确定他们的近视程度。 进展，并测量其眼部成分。 他们的愿景 更正将每六个月更新一次。 CLAMP研究是培训博士的理想研究范围和规模。 沃林成为一名独立调查员， 改变幼儿护理标准的潜力， 近视眼。