Glaucoma and Driving Licence: How to Identify Patients at Risk of Having it Revoked
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of Visual Field quality by combining two parameters obtained by Computerized Visual Field Examination: number of missed points within the central 20° visual field and average Sensitivity (AS) of all the 60 points of the 24-2 grid
研究概览
简要总结
The aim of the study is to identify clinical criteria, easily achievable with patient's follow-up tests, which can identify individuals at increased risk of being unfit to drive. Only they, then, will be directed to further investigations. These clinical standards should also be suitable for implementing or substituting the current law's criteria, after appropriate additional studies, so that the law can be based on the clinic.
详细描述
In this observational study, the investigators recruite patients referred at the Glaucoma Service of the Ophthalmologic Clinic of the ASST Sette Laghi University Hospital in Varese.
All the patients enrolled in the study require a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (Humphrey SITA 24-2 or 30-2 SITA Standard) performed in the previous six months.
All patients undergo a full ophthalmologic examination and verbally submitted a questionnaire designed by the authors of the paper (LL, SD, MD).
The examination included Visual Acuity, refraction, slit lamp bio-microscospy, Goldmann's applanation tonometry, gonioscopy with four mirror lens, OCT RNFL and GCL imaging if necessary and re-evaluation of target IOP.
The investigators use the two monocular visual fields to build an Integrated Visual Field which, according to D.P. Crabb papers, is an efficient surrogate to the Binocular Esterman Visual Field Test (EVFT). In short, each point in each monocular field is compared to its equivalent in the other eye, and the data, from the eye with the best sensitivity, are used. Locations are dichotomized into groups with sensitivity > 10 dB and < 10 dB, representing whether a patient would see or miss a point in the Esterman test, respectively. To match even better the IVF with the EVFT, 8 points of the inner 20° of the IVF were excluded since they have no direct equivalent in the EVFT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •subjects above 18 years of age
- •clear diagnosis of Glaucoma (of any type)
- •to show a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (Humphrey SITA 24-2 or 30-2 SITA Standard) performed in the previous six months.
排除标准
- •other ocular conditions that could affect the visual field (i.e. cataract or macular degeneration).
- •patients that underwent a 10-2 test since it does not allow the composition of the Integrated Visual Field.
结局指标
主要结局
Evaluation of Visual Field quality by combining two parameters obtained by Computerized Visual Field Examination: number of missed points within the central 20° visual field and average Sensitivity (AS) of all the 60 points of the 24-2 grid
时间窗: Baseline
The Visual Field quality will be evaluated by considering two variables: Number of missed points within the central 20° visual field (expressed in number) and average Sensitivity (AS) of all the 60 points of the 24-2 grid (expressed in decibel, dB)
次要结局
- Creation of a Integrated Visual Field of both eyes(Baseline)
研究者
Simone Donati
Associate Professor
Università degli Studi dell'Insubria
