Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- fixation stability measured by microperimetry and exudative signs on OCT
研究概览
简要总结
ARMD is the main cause of visual disability after 50 years old in France. Patients with active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular OCT but also on angiography when necessary).
The aim of this study is to evaluate the link between active neovascularization found on OCT and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.
Quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up for each patient. The mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered.
In case no link will be found, for instance bad fixation quality without exudative signs on OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients > 50 years old,
- •With neovascular ARMD
- •who need an induction treatment (de novo patients or patients who had their last intravitreal injection of antiVEGF more than 6 months ago)
排除标准
- •Other maculopathies
- •Severe glaucoma with central visual field defect
- •Diabetic patients
- •Corneal, lens or vitreous opacities interfering in OCT analysis
- •Attention or comprehension deficit
结局指标
主要结局
fixation stability measured by microperimetry and exudative signs on OCT
时间窗: 2 years
quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up. The fixation stability is classified as follows: * Stable if more than 75% of the fixation points are contained inside the circle of 2 degrees of diameter * Relatively unstable if more than 75% of the fixation points are contained within the circle of 4 degrees of diameter and less than 75% contained within that of 2 degrees of diameter * Unstable if less than 75% of the fixation points are contained within the circle of 4 degrees of diameter
次要结局
- mean central retinal sensitivity(2 years)
- Bivariate Contour Ellipse Area (BCEA) value(2 years)
- Best Corrected Visual Acuity (BCVA)(2 years)