TELEGLAUCOMA: THE NJ HEALTH FOUNDATION STUDY a Prospective, Single Site, Masked Study Comparing the Diagnostic Accuracy and Management Recommendations of Teleglaucoma to Conventional Clinical Care in Patients With Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Comparison of diagnosis and management in Teleglaucoma and conventional care
研究概览
简要总结
Telemedicine allows screening of subjects with limited access to eye care. Failure of screenees to come for full examination was identified as a serious problem. Teleglaucoma should allow a single physician access to screenees in real time. The investigators aim to test the technical feasibility of developing a system for teleglaucoma that will allow a physician real time access to patient information and images and compare it to traditional physical presence evaluation in glaucoma clinics. This system can be applied during telemedicine for glaucoma and other vision threatening diseases.
详细描述
Research Plan including Methods
Investigators propose to develop a program for teleglaucoma and to validate it for patient care outcomes. The study will be conducted in two phases. The first phase will establish the technical foundation for the teleophthalmology system; the second phase will investigate the clinical impact of teleglaucoma.
Phase I: Investigators will develop and test technical aspects of a teleophthalmology system for glaucoma. Phase II will evaluate the impact of teleglaucoma on patient care outcomes.
Phase I. Development and Validation of a Teleophthalmology System in Glaucoma. By partnering with an ongoing telemedicine program at the Institute of Ophthalmology & Visual Science (IOVS), investigators will develop and test a system for telemedicine in glaucoma. In this phase, a wireless secure telemedicine system will be assembled that allows real-time access to participant subject screening data and images. The teleophthalmology system will be used and tested during telemedicine screening operations that are conducted by the investigators telemedicine team monthly in NJ. Telemedicine screenings occur all over the state of NJ at community centers, schools, places of worship, soup kitchens, other.
Telemedicine system component assembly: Integration to imaging equipment, setup, installation, and training of personnel will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
盲法说明
Investigators in teleglaucoma and conventional glaucoma clinics are masked to one another
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with glaucoma or who are glaucoma suspects
排除标准
- •Physical limitations precluding image acquisition like the inability to position for imaging or the inability to acquire images/testing
研究组 & 干预措施
Tele-Glaucoma arm
Subjects enrolled in tele-glaucoma arm for remote assessment
干预措施: Teleglaucoma (Diagnostic Test)
结局指标
主要结局
Comparison of diagnosis and management in Teleglaucoma and conventional care
时间窗: 24 months
Qualitative categorical outcome: Glaucoma Diagnosis, Management and follow up are clinical determinations by the investigator that are based on the overall clinical evaluation of the subject Diagnosis: A. no glaucoma B. confirmed glaucoma Management: A. maintain current therapy, B. advance therapy (additional glaucoma medication or surgical glaucoma intervention), C. no therapy needed Follow up: A. urgent (less than 4 weeks from time of evaluation) B. routine (more than 4 weeks from time of evaluation)
次要结局
- Assessment of diagnostic tools during teleglaucoma: Visual acuity(12 months)
- Assessment of diagnostic tools during teleglaucoma: Tonometry(12 months)
- Assessment of diagnostic tools during tele glaucoma: Optic nerve(12 months)
- Assessment of diagnostic tools during tele glaucoma: Optical Coherence Tomography(12 months)
研究者
Albert S Khouri, MD
Associate Professor
Rutgers University