Wills Eye Community Intervention to Improve Glaucoma Detection and Follow-up Care

描述（由申请人提供）：青光眼是一种慢性视神经病变，导致视野缺损和进行性、不可逆的视力丧失。青光眼是美国第二大致盲原因。原发性开角型青光眼是最常见的类型。到2020年，青光眼的发病率预计将增加50%，达到336万人，造成重大的经济和生活质量负担。青光眼的风险因素包括高龄（65岁以上）、青光眼家族史、种族（非洲裔美国人、亚洲人）和种族（西班牙裔/拉丁裔）。糖尿病也是青光眼的独立危险因素。非裔美国人在更年轻的时候患上青光眼，进展更快，并且比非西班牙裔白人失明的可能性高出近7倍。尽管有先进的技术和可用的诊断测试，50%的青光眼患者仍然未被诊断出来。当青光眼在早期被诊断时，适当的治疗和管理几乎总是可以防止失明。在L. Jay Katz，MD; Julia A. Haller，MD; Wills眼科青光眼研究中心和丽莎Hark博士将进行一项为期5年的前瞻性随机对照试验，以测试一种创新的社区干预，使用视神经和黄斑的眼底摄影（远程医疗）来检测、治疗和管理患有先前未诊断的青光眼和其他眼科疾病的高危患者。我们多样化的目标高危人群包括40岁以上的非洲裔美国人、西班牙裔和亚洲人;老年人（65岁以上）;以及40岁以上有青光眼和/或糖尿病家族史的人。第一阶段将包括从费城和切斯特县的14个初级保健办公室和10个联邦合格的健康中心与我们的社区合作伙伴招募大约2,000名患者。使用远程医疗，我们将使用远程医疗检测眼病（访视1），然后由青光眼专家进行全面的眼科检查以确认诊断（访视2）。根据初步数据，30%的患者（约600例）将出现视神经和/或黄斑图像异常。将评价视神经图像检测青光眼和经综合眼科检查确认的疑似青光眼的预测准确性。第2阶段将涉及同意、入组并将300例患者随机分配至常规治疗组（n=150）或强化干预组（n=150），并安排当地普通眼科医生进行随访眼科检查（访视3）。加强干预将包括使用患者导航员和社会工作者，以减少后续眼科护理的障碍。第3阶段将包括在患者接受眼科预约（访视4-8）时对患者进行近端（6个月）和远端（3年）随访。对眼科护理随访建议的依从性将是主要的结局指标。此外，我们亦会进行全面的成本研究，以评估为高危人士检测眼疾和视力受损的介入成本和成本效益。方案、材料和结果将传播到其他社区，以扩大青光眼、其他眼病和视力障碍的检测，并进一步完善这些方法。

DESCRIPTION (provided by applicant): Glaucoma is a chronic optic neuropathy resulting in visual field defects and progressive, irreversible vision loss. Glaucoma is the second leading cause of blindness in the United States. Primary open-angle glaucoma is the most common form. Rates of glaucoma are projected to increase by 50% to 3.36 million people by 2020, causing a significant economic and quality of life burden. Risk factors for glaucoma include advanced age (65+ years), family history of glaucoma, race (African American, Asian), and ethnicity (Hispanic/Latino). Diabetes is also an independent risk factor for glaucoma. African Americans develop glaucoma at a younger age, progress more rapidly, and are almost 7 times more likely to go blind than non-Hispanic Caucasians. Despite the advanced technology and available diagnostic testing, 50% of people with glaucoma remain undiagnosed. When glaucoma is diagnosed in its early stages, appropriate treatment and management can almost always prevent blindness. Under the leadership of L. Jay Katz, MD; Julia A. Haller, MD; and Lisa Hark, PhD, RD, the Wills Eye Glaucoma Research Center will conduct a 5-year prospective, randomized controlled trial to test an innovative community intervention using fundus photography of the optic nerve and macula (telemedicine) to detect, treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye diseases. Our diverse, targeted at-risk population includes African Americans, Hispanics and Asian over age 40; older adults (aged 65+); and those over age 40 with a family history of glaucoma and/or diabetes. Phase 1 will consist of recruiting approximately 2,000 patients from 14 primary care offices and 10 federally qualified health centers across Philadelphia and Chester counties with our community partners. Using telemedicine, we will detect eye disease using telemedicine (Visit 1) followed by a comprehensive eye exam by a glaucoma specialist to confirm the diagnosis (Visit 2). Based on preliminary data, 30% of patients (approximately 600) will have abnormal optic nerve and/or macula images. The predictive accuracy of the optic nerve images to detect glaucoma and glaucoma suspect as confirmed by the comprehensive eye exam will be evaluated. Phase 2 will involve consenting, enrolling, and randomizing 300 patients to either the usual care group (n=150) or the enhanced intervention group (n=150) and scheduling follow-up eye exams with local, general ophthalmologists (Visit 3). The enhanced intervention will consist of using patient navigators and a social worker to reduce barriers to follow-up eye care. Phase 3 will consist of following patients proximally (6 months) and distally (3 years) while they attend ophthalmology appointments (Visits 4-8). Adherence to follow-up recommendations for eye care will be the primary outcome measure. A comprehensive cost study to estimate the intervention costs and cost-effectiveness of detecting eye diseases and vision impairment in a high-risk population will also be conducted. Protocols, materials, and results will be disseminated to other communities in order to expand detection of glaucoma, other eye diseases, and visual impairment, and to further refine these approaches.