RADIAL KERATOTOMY

放射状角膜切开术

• 批准号: 2158905
• 负责人: MICHAEL J LYNN
• 金额: $ 23.83万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1980
• 资助国家: 美国
• 起止时间: 1980-09-30 至 1996-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2158905
• 关键词: cooperative study; data collection methodology /evaluation; human subject; human therapy evaluation; longitudinal human study; myopia; patient /disease registry; radial keratotomy

The Purpose of this grant is to fund the Statistical Coordinating Center for the Prospective Evaluation of Radial Keratotomy (PERK) study to examine the patients at ten years after surgery. Radial keratotomy is the most frequently done refractive corneal surgical procedure; approximately 150,000 cases are being done annually in the United States and hundreds of thousands more worldwide. It is important to document the efficacy, safety. stability. and predictability of the procedure over the long-term. The rationale and specific research questions of this study are given in the application for the Clinical Coordinating Center. The Statistical Coordinating Center will be responsible for the following tasks to prepare for and carry out the collection. analysis, and interpretation of the 10 year followup data: (1) maintain current PERK study data; (2) maintain patient information data for tracking and contacting PERK patients; (3) collaborate in the development of the protocol for the 10-year examination; (4) prepare for the training of data coordinators for the nine clinical centers; (5) develop and test data collection forms and procedures; (6) enter, verify. edit and update the data from the clinical centers; (7) prepare reports on clinical performance and patient status; (8) prepare presentations and manuscripts of the study results; (9) plan and carry out the closeout of the clinical centers; (10) if warranted. based on the results of the 10 year examination, make initial preparations for a subsequent 15 year examination of the patients in the PERK study.

这笔赠款的目的是为统计协调中心提供资金 用于对径向角化切开术（PERK）研究的前瞻性评估 手术后十年的患者。 径向角膜切开术是最大的 经常进行折射角膜外科手术；大约 每年在美国每年进行15万例案件和数百例 全世界有成千上万的人。 记录功效很重要， 安全。稳定。从长期来看该程序的可预测性。 这项研究的理由和具体研究问题在 临床协调中心的应用。 统计协调中心将负责以下 准备和执行收藏的任务。分析和 对10年随访数据的解释：（1）保持当前的振兴 研究数据； （2）维护患者信息数据以进行跟踪和 联系PERK患者； （3）合作开发 10年考试的协议； （4）准备数据培训 九个临床中心的协调员； （5）开发和测试数据 收集表和程序； （6）输入，验证。编辑和更新 来自临床中心的数据； （7）准备有关临床表现的报告 和患者身份； （8）准备研究的演讲和手稿 结果; （9）计划并执行临床中心的关闭； （10） 如果有必要。根据10年考试的结果，首先 随后对患者进行15年检查的准备工作 PERK研究。