Glaucoma Telemedicine Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Successful fundus imaging of 90 % enrolled patients.
研究概览
简要总结
The incidence of glaucoma is currently growing in the world's population, including the younger ones. However, the number of specialists who could perform examinations is unavailable in many areas of the Czech Republic outside large agglomerations. There is suitable alternative procedure that would make it possible to increase the intensity of screening, for example in general practitioners surgeries via application of teleophthalmology. Early detection is absolutely essential for the patient (and therefore the health care system) for his/her further successful treatment. At the same time, all the necessary technical prerequisites are well known and commercially available.
详细描述
Detailed Description: The aim of this study is to increase the detection of patients suspected of having glaucoma. For this purpose, the use of a combination of a mobile fundus camera and a mobile intraocular tonometer is proposed. These devices are used within the general practitioners' surgeries in the rural parts of Olomouc and Jeseniky region. Their combination will allow a better stratification of patients suspected of glaucoma into the following groups:
- patients with ocular hypertension (higher intraocular pressure and normal optic disc)
- patients with normotensive glaucoma (normal intraocular pressure and suspected optic disc)
- glaucoma patients (higher intraocular pressure and suspected optic disc)
The advantage of involving a fundus camera is also in the possibility of the retinal pathologies detection such as diabetic retinopathy or age-related macular degeneration as a secondary outcome of the study.
However, the primary goal of the study is to detect glaucoma and ocular hypertension. This area is also supported by the Risk Factors Questionnaire and the Patient Education Questionnaire.
All patients will be evaluated by University hospital Olomouc (FNOL) ophthalmology specialists who will evaluate data coming through the specifically designed FNOL telemedicine webportal from intraocular tonometers and fundus cameras. Suspected patients will be invited to the FNOL Eye Clinic for follow-up assessment using other modalities - perimeter, OCT, stationary fundus camera, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age
- •Informed written and verbal consent
排除标准
- •Absence of collaboration (informed consent)
结局指标
主要结局
Successful fundus imaging of 90 % enrolled patients.
时间窗: 3 month
90% of captured fundus images are useful for subsequent diagnostics by the ophthalmologist located remotely.
Successful stratification of 90 % enrolled patients into groups with use of intraocular tonometer.
时间窗: 4 month
Differentiation of 90 % enrolled patients into the following groups: * patients with ocular hypertension (higher intraocular pressure) * patients with normotensive glaucoma (normal intraocular pressure) * glaucoma patients (higher intraocular pressure)
Successful stratification of 90 % enrolled patients into groups with use of fundus camera.
时间窗: 4 month
Differentiation of 90 % enrolled patients into the following groups: * patients with ocular hypertension (normal optic disc) * patients with normotensive glaucoma (suspected optic disc) * glaucoma patients (suspected optic disc)
Successful intraocular pressure measurement of 90 % enrolled patients.
时间窗: 3 month
90% of measured intraocular pressures are useful for subsequent diagnostics by the ophthalmologist located remotely.
Invitation of all suspected patients within 1 month timeframe after the diagnosis to the premises of University hospital Olomouc for aditional assessment.
时间窗: 4 month
Patients that were identified as suspected by the funduscopy and intraocular tonometry are subsequently invited for further assessment into the hospital.
次要结局
未报告次要终点
研究者
Ladislav Stanke
Principal Investigator
University Hospital Olomouc