Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Compare the progression of vascular density (VD) in advanced glaucoma patients.
研究概览
简要总结
Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.
To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.
The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).
详细描述
Glaucoma is a chronic disease of the optic nerve characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second-leading cause of blindness after cataracts and the leading cause of irreversible blindness.
The pathophysiology and loss of retinal ganglion cells are partly explained by 2 main theories:
- biomechanical theory, which takes into account the forces and deformations of the optic nerve linked to IOP (intraocular pressure) and to the anatomy of the optic nerve head, particularly at the level of the cribriform plate (a zone of deformable weakness surrounded by a rigid scleral shell),
- the vascular theory, explained by abnormalities in the vascularization of the optic nerve and retina.
Optical coherence tomography angiography (OCTa) is a relatively new imaging method that has been on the market for around ten years.
It is a non-invasive method that provides qualitative and quantitative information on retinal vascularization and the optic nerve head. The movement of red blood cells is used as a contrast medium to differentiate blood vessels from static tissue.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 and over
- •Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital
- •mean visual field deficit (MD) >10dB
排除标准
- •Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...)
- •PPR (retinal PanPhotocoagulation), retinal cerclage
- •Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa)
- •AMD and other macular pathologies that can lead to central visual field deficits
- •Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract)
- •Loss of fixation point preventing visual field formation Pregnant or breast-feeding women
- •Protected adults under guardianship or curatorship
- •with unreliable visual fields (false positives and false negatives > 33%)
- •with an uninterpretable OCTrnfl or OCTa (artifact, low quality score)
结局指标
主要结局
Compare the progression of vascular density (VD) in advanced glaucoma patients.
时间窗: 3 year
Progression of peripapillary vascular density (VD) (in percent) per sector (8 sectors) with 3-year follow-up.
Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients.
时间窗: 3 year
Progression of peripapillary nerve fiber thickness (RNFL, in µm) per sector (8 sectors) with 3-year follow-up.
Compare the progression of visual field in advanced glaucoma patients.
时间窗: 3 year
Progression of visual field deficit (in dB) by sector (8 sectors) with 3-year follow-up
次要结局
- CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up(3 years)