Large Cohort of 1000 Patients With Severe Myopia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Retinal sensitivity and fixation stability
研究概览
简要总结
The prevalence of myopia and severe myopia are increasing and will affect 50% and 10% of the population respectively. Severe myopia exposes an increased risk of glaucoma, cataract, retinal detachment and myopic maculopathy, a source of visual impairment.
To date, no European cohort study has been conducted to estimate the rate of these complications and to study the predictive parameters.
详细描述
This study allows to describe the evolution of different ophthalmological parameters of a population of strong myopes during their follow-up for 10 years using multimodal imaging techniques of the retina.
Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection.
This study will include major and minor patients with high myopia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 6 years
- •Severe myopia in at least one eye, defined as
- •a refractive error ≤ -6.00 diopters OR
- •an axial length ≥ 26.50 mm
- •Follow-up performed at at least one of the participating centers
- •Express consent to participate in the study
- •If age < 18 years: express consent of the person(s) exercising parental authority
- •Affiliated or beneficiary of a health insurance
排除标准
- •Visual acuity < 5 letters on the ETDRS (equivalent to "finger count" or less) in both eyes
- •Disorders of the transparent media in both eyes with opacities that may affect image quality
- •Syndromic myopia of genetic origin (Stickler syndrome type 1 and 2, Marfan syndrome, Ehler-Danlos disease type 4, Knobloch syndrome) or inherited retinal dystrophy (X-linked retinitis pigmentosa, congenital stationary night blindness of Schubert-Bornshein type, Bornholm eye disease)
- •Patient who does not wish to continue to be followed in one of the participating centers
- •Patient benefiting from a legal protection measure
- •Pregnant or breastfeeding woman
结局指标
主要结局
Retinal sensitivity and fixation stability
时间窗: 10 years
Respectively Performed in decibels and by microperimetry
Axial length
时间窗: 10 years
Will be performed in mm
Area of Rétinal atrophy
时间窗: 10 years
In autofluorescence (in mm²)
Characterization of the type of staphyloma
时间窗: 10 years
staphyloma classification
qualitative data on OCT :
时间窗: 10 years
presence of any macular complications: * condition of the posterior vitreous * presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...).
Anterior segment status
时间窗: 10 years
Chamber measurement, corneal curvature (in mm)
Visual acuity
时间窗: 10 years
Using the ETDRS and the near vision scale (decimal scales converted to logMAR)
Refraction measures
时间窗: 10 years
Measure will be performed in diopter
Excavation of the optic nerve and area
时间窗: 10 years
In mm² of peripapillary atrophy on color and autofluorescence images
Intraocular pressure and pachymetry
时间窗: 10 years
These measurements are respectively carried out in mmHg and in μm
Central visual field deficits
时间窗: 10 years
by automatic perimetry in decibels
Quantitative data
时间窗: 10 years
On optical coherence tomography (OCT) and OCT-Angiography
Vitreous status
时间窗: 10 years
Liquefaction, stage of posterior vitreous detachment
Lens opacity
时间窗: 10 years
Measure will be performed in pixel units
次要结局
- Macular ophthalmologic complications(10 years)
- Non-macular ophthalmologic complications(10 years)