Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS): Artificial Intelligence Applied to Optic Nerve Retinographies for a Glaucoma Screening Program in a Primary-care Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Diagnostic agreement between the AI software and the ophthalmic examination
研究概览
简要总结
Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care.
Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit, with an optic disc examination and intraocular pressure (IOP).
The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit (IPU) the patients will be allocated to: one arm using an Artificial Intelligence (AI) reading software of the optic disc picture; and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist.
In both circuits, an optic nerve head photography will be obtained, and a masked reading center will be established to determine the ground truth for diagnosis.
This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them.
Secondary analyses will include potential diagnostic composite scores (including other ancillary tests, such as optical coherence tomography images, that could maximize the screening process); the identification of population and disease characteristics (type of glaucoma, intraocular pressure) that could increase the effectivity and adherence to the screening process.
详细描述
The purpose of this study is twofold: to validate in our population an Artificial Intelligence (AI) reading software of the optic disc picture, after comparing the estimated result (glaucoma/suspect/normal) to the ground truth; and to conduct a clinical trial where the level of agreement between both systems and the cost-effectiveness of each of them will be tested
In the first phase, a set of patients from our reference population will be selected. A standard-of-care ophthalmic examination with the usual ancillary tests to confirm or rule out the presence of glaucoma (including an optic disc retinography), will be performed. The patient (and the test) will be examined by a glaucoma specialist who will determine the status of the patient.
Then, the retinography will be analyzed by the AI software, providing the estimated result (glaucoma/suspect/normal). The level of agreement between the ground truth and the casted result will confirm the diagnostic accuracy.
In the second phase, a second set of patients will be recruited. In this case, the patients will be randomly allocated to either of the two arms of the study: In arm A the ancillary tests (including the retinography) will be performed, and the software will analyze the retinography, therefore providing the glaucoma status result. In arm B, the patients (and the test) will be examined by a glaucoma specialist who will then determine the status of the patient.
All the patients, irrespective of the diagnosis and the arm of the study will be then explored by another glaucoma specialist (reading center), who will be blinded to where the diagnosis comes from (AI software or glaucoma specialist), to the determine the level of agreement between the two screening systems
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 40 to 80 years old from our reference population
- •Family history of glaucoma
- •Willingness to participate
- •Signed written informed consent
排除标准
- •Not signing the informed consent
- •Patients that had a previous diagnosis of glaucoma or any ophthalmic disease that required a regular ophthalmic examination and/or treatment
- •Congenital or childhood glaucoma
- •History of strabismus or amblyopia
- •Known ophthalmic diseases which imply media opacity (cataract, cornea opacities) that might preclude from taking fundus retinographies
结局指标
主要结局
Diagnostic agreement between the AI software and the ophthalmic examination
时间窗: 18 months
Level of agreement between the casted result by the AI software and the ophthalmic examination. This will be determined by the reading person (study chair)
Health-Related Quality of Life (HRQoL)
时间窗: 18 months
Health-Related Quality of Life (HRQoL) assessed by Euro Quality of Life -5 Dimensions (EQ-5D), for each arm of the clinical trial. It consists of a visual analog scale, ranging from 0 to 100 (0 being the worst imaginable health and 100 the best health the patient can imagine)
Demographics
时间窗: 18 months
Quantitative analysis of age, gender, ethnicity, and family history of glaucoma differences between the two arms
次要结局
- Optical coherence tomography (OCT)(18 months)
- Cost-effective analysis of both screening methods(18 months)
- Visual field(18 months)
- Risk score with parameters associated with positive screening of glaucoma(6 months)
- Intraocular pressure(18 months)