温州医科大学附属眼视光医院成立于1998年，是浙江省首家三级甲等眼科专科医院，全面承担临床医疗、医学教育、医学科研、预防保健等任务。医院汇聚多个国家级科研与临床重点平台，包括眼和视光疾病国家临床医学研究中心、国家药监局眼科疾病药物和医疗器械临床研究与评价重点实验室、国家眼科学临床重点专科、眼视光学和视觉科学国家重点实验室、国家眼视光工程技术研究中心以及教育部近视防控与诊治工程研究中心。在国家三级公立医院绩效考核中，医院成绩卓著：连续3年位居全国眼科专科医院榜首，"其他专科手术组" 位列全国第2名；更连续5年荣获专科医院最高A等奖，彰显雄厚综合实力。

Founded in 1998, the Eye Hospital of Wenzhou Medical University is the first Grade III Class A ophthalmic specialist hospital in Zhejiang Province. It fully undertakes clinical services, medical education, medical research, and preventive health care. The hospital has gathered multiple national-level key scientific research and clinical platforms, including the National Clinical Research Center for Eye Diseases, Key Laboratory of Clinical Research and Evaluation for Ophthalmic Drugs and Medical Devices (National Medical Products Administration), National Key Clinical Specialty in Ophthalmology, State Key Laboratory of Ophthalmology, Optometry and Visual Science, National Engineering Research Center for Ophthalmology and Optometry, and Engineering Research Center for Myopia Prevention, Control and Treatment (Ministry of Education). In the performance assessment of national Grade III public hospitals, the hospital has achieved remarkable results: it has ranked first among ophthalmic specialist hospitals in China for three consecutive years, with its "Other Specialist Surgery Group" ranking second nationwide; furthermore, it has won the highest A-level award among specialist hospitals for five consecutive years, demonstrating its strong comprehensive strength.

医院药物临床试验中心于 2005年通过国家药物临床试验机构资格认定。2010年，中心顺利通过机构资格现场复核检查（证书编号：XF20120128）；2013年获批国家科技重大新药创制 "眼视光药物临床试验平台"。2017年，中心再次通过机构资格现场复核检查，展现卓越且稳定的专业水准。

The hospital's Drug Clinical Trial Center obtained the qualification accreditation of national drug clinical trial institutions in 2005. In 2010, the center successfully passed the on-site re-inspection of institutional qualifications (Certificate No.XF20120128); in 2013, it was approved as the "Ophthalmology and Optometry Drug Clinical Trial Platform" under the National Major Science and Technology Project for New Drug R&D. In 2017, the center passed the on-site re-inspection of institutional qualifications again, demonstrating its excellent and stable professional standards.

依据国家相关部门要求，中心于2020年完成药物临床试验机构备案（含Ⅰ期药物临床试验，备案号：药临床机构备字2020000406）；2022年完成器械临床试验备案（备案号：械临机构备201800278），进一步规范和完善了临床试验相关资质。中心严格遵循我国《药物临床试验质量管理规范》《器械临床试验质量管理规范》（GCP）及 ICH-GCP指南，具备开展药物Ⅰ-Ⅳ期临床试验的专业能力。研究重点聚焦眼科药物临床药理学、药代动力学，以及眼科新药和医疗器械的前沿探索，为眼科领域的医学发展持续贡献力量。

In accordance with the requirements of relevant national authorities, the center completed the filing for drug clinical trial institution in 2020 (covering Phase I drug clinical trials, Drug Clinical Trial Institution Filing No.2020000406); in 2022, it completed the filing for medical device clinical trials (Medical Device Clinical Trial Institution Filing No.201800278), further standardizing and improving qualifications related to clinical trials. The center strictly adheres to China's Good Clinical Practice (GCP) for Drugs, Good Clinical Practice (GCP) for Medical Devices, and ICH-GCP guidelines, and has the professional capability to carry out Phase I-IV clinical trials of drugs. Its research focuses on clinical pharmacology and pharmacokinetics of ophthalmic drugs, as well as cutting-edge exploration of new ophthalmic drugs and medical devices, continuously contributing to medical development in the field of ophthalmology.

机构主任由温州医科大学原校长瞿佳教授担任，副主任由温州医科大学附属眼视光医院副院长陈蔚担任，他们共同组建了完善的管理团队，成员包括办公室主任、机构办秘书、项目管理员、质控员、药品管理员、院内研究协调员、资料管理员等。自2018年起，机构积极发挥行业引领作用，牵头承办及协办院内外 GCP 培训 8 次，内容涵盖药物 / 器械临床试验质量规范、Ⅰ期临床试验要点、项目质控技能提升等关键领域，累计培训1700多人次。2023年起，医院为进一步推动临床研究事业发展，特开设临床研究进修学习项目，课程内容全面深入，涵盖临床试验机构备案、管理、项目管理、质量控制、CRC/CRA 管理、试验用药品中心化管理、眼科专业组实践Ⅰ期病房及研究团队轮转等模块，全力为行业培养专业人才。2024年度，机构在全国 GCP 机构药物临床试验量值排行榜中成绩优异，"其他专科" 排名第7，在眼科专科医院中独占鳌头。

The institution is headed by Professor Qu Jia, former President of Wenzhou Medical University, with Professor Chen Wei, Vice President of the Eye Hospital of Wenzhou Medical University, serving as the deputy director. Together, they have built a well-established management team，including office director, institutional office secretary, project managers, quality controllers, drug administrators, in-house research coordinators, and data managers. Since 2018, the institution has actively played a leading role in the industry by spearheading and co-organizing 8 GCP training sessions both internally and externally. These programs cover key areas such as drug/device clinical trial quality standards, essentials of Phase I clinical trials, and improvement of project quality control skills, with a total of over 1,700 person-times trained. Starting from 2023, to further promote the development of clinical research, the hospital has launched a clinical research advanced study program. The program offers comprehensive and in-depth courses covering modules such as clinical trial institution registration, management, project management, quality control, CRC/CRA management, centralized management of investigational drugs, ophthalmology professional group practice, and rotations in Phase I wards and research teams, striving to cultivate professional talents for the industry. In 2024, the institution achieved excellent results in the National GCP Institution Drug Clinical Trial Volume Ranking, ranking 7th in the "Other Specialties" category and leading among ophthalmic specialist hospitals.

机构下设Ⅰ期临床试验研究室、药物临床试验中心办公室和眼科药物临床试验研究室。Ⅰ期临床试验研究室设施完备，设有临床试验专用病房（固定床位30张）、受试者接待室、样本采集室、活动室、休息室，配备独立抢救室与先进的急救设施，及专业的临床试验技术人员。此外，医院与温医大附属第一、第二医院搭建急救绿色通道，全方位保障受试者安全。该研究室配备分子生物学和药理学实验室，既能承接临床前研究，又重点聚焦创新药在眼科领域的临床药理学研究。

The institution has three subordinate units: the Phase I Clinical Trial Laboratory, the Office of the Drug Clinical Trial Center, and the Ophthalmic Drug Clinical Trial Laboratory. The Phase I Clinical Trial Laboratory is well-equipped with dedicated wards for clinical trials (30 fixed beds), a subject reception room, a sample collection room, an activity room, and a lounge. It is equipped with an independent rescue room, advanced first-aid facilities, and professional clinical trial technicians. In addition, it has established green emergency channels with the First and Second Affiliated Hospitals of Wenzhou Medical University to ensure the safety of subjects in an all-round manner. Equipped with molecular biology and pharmacology laboratories, this research laboratory can both undertake preclinical studies and focus on clinical pharmacology research of innovative drugs in the field of ophthalmology.

近二十年来，机构积极投身临床试验工作，已开展400多项临床试验，在眼科新药和器械临床研究与评价方面积累深厚实践经验，锤炼出一支技术过硬、专业素养高的中青年技术骨干队伍，为眼科医疗领域的创新发展持续注入活力。

Over the past two decades, the institution has actively engaged in clinical trial work and carried out more than 400 clinical trials. It has accumulated profound practical experience in the clinical research and evaluation of new ophthalmic drugs and devices, and cultivated a team of young and middle-aged technical backbones with excellent skills and high professional quality, continuously injecting vitality into the innovative development of the ophthalmic medical field.