Screening Trial for Glaucomatous Optic Discs in Portugal
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 6,000
- 试验地点
- 6
- 主要终点
- Diagnostic agreement between referring decision and reading center decision
研究概览
简要总结
Two primary care-based screening systems will be used to identify subjects with referrable glaucoma to hospital care.
Subjects between 55 to 65 years old living in two primary care areas (urban area in Lisbon ; countryside setting in Minho) will be invited to a one-time assessment of optic disc and intraocular pressure (IOP).
Criteria for referral will differ between centers, with one arm (Lisbon) using an artificial intelligence (AI) reading software of the optic disc picture, the other (Minho) will base their referral based on optical coherence tomography (OCT) retinal nerve fibre layer abnormality.
A masked reading center will be established to set the ground truth for diagnosis.
This pilot screening trial will explore the level of agreement between both systems as well as their cost effectiveness and identify diagnostic composite scores that could maximize the screening process. Secondary analyses will include the identification of population characteristics that increase effectivity of screening process as well as determining the population less likely to adhere to screening programmes.
详细描述
Glaucoma diagnosis is currently based on opportunistic case finding, which makes the case for up to 50% of patients remaining undiagnosed. Diagnostic technology has been deemed efficient in diagnosing, but cost and (hospital) location acts as a barrier for effective screening for this asymptomatic disease with a low population-based prevalence
Portuguese National Strategy for Visual Health, published in 2018 asks for a pilot study aimed at a one-time intervention at the primary care setting at the age of 60 years to do both an optic disc analysis and an intraocular pressure (IOP) measurement as a screening system for glaucoma
Two Portuguese centers have applied for this pilot. An urban-based center (Lisbon) and a countryside center (Minho) will conduct an invitation-based screening for those registered in their global primary care area. Age range was increased to 55 to 65 to capture a spectrum of data, enabling to later refine the target population.
Screening Intervention will be the same in both centers. Both will assess reasons for undergoing or rejecting screening and demographic and ophthalmological-related parameters, including glaucoma family history and a known personal glaucoma diagnosis. IOP will be non-invasively checked by rebound tonometry and optic disc retinographies will be performed on both centers. The Minho arm will additionally perform an optical coherence tomography (OCT) on all subjects.
Decision to refer will be made on one (or both) two findings:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two physicians (unrelated to any recruiting center) will have access to pseudonymized data, masked to both screening and hospital decisions.
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects age between 55 to 65 years old registered in the primary care area of either ACES Lisbon Norte (Lisbon arm) or in the area of ACES Alto Minho (Minho arm)
- •willingness to sign an informed consent for the screening process
排除标准
- •Poor quality in screening image will be included in the intention to treat analysis, but excluded from the diagnostic comparator outcome.
- •Patients with a known glaucoma diagnosis will not be excluded from the screening
结局指标
主要结局
Diagnostic agreement between referring decision and reading center decision
时间窗: Duration of the study (8 months)
Level of agreement will be done between referring decision and the ground truth as assessed by the reading center (normal, glaucoma suspect; definitive glaucoma). All subjects from both centers (referred and non-referred) will be reviewed. For a primary outcome analysis, the middle category (glaucoma suspect) will be pooled together with the normal diagnosis
次要结局
- Comparison between level of agreement (with ground truth) from both screening models(Duration of the study (8 months))
- Cost effective analysis of both screening models(Duration of the study (8 months))
- Level of performance of agreement by number of diagnostic testing(Duration of the study (8 months))
- Subjects parameters associated with positive screening(Duration of the study (8 months))
- Parameters associated with accepting screening system by the patients(Duration of the study (8 months))
- Level of agreement (in %) between AI-risk score and human-based assessment of disease severity(Duration of the study (8 months))
研究者
Luis Abegao Pinto
Prof. Dr.
Centro Hospitalar Universitário Lisboa Norte