Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
试验速览
- 阶段
- 不适用
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Perfusion density
研究概览
简要总结
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.
详细描述
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.
Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 Participants can have 1 or 2 study eyes
- •Patient Group:
- •Diabetes mellitus type 1 or 2
- •Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR
排除标准
- •Substantial media opacities that would preclude successful imaging
- •Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
- •Structural damage to the center of macula in the study eye
- •History of prior panretinal photocoagulation
- •History of treatment with intravitreal agents over the prior 6 months
- •Macular edema involving the central subfield
- •Prior history of vitrectomy
- •Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
- •Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
- •Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
- •Inability to obtain fundus images of sufficient quality to be analyzed and graded
结局指标
主要结局
Perfusion density
时间窗: 6 months
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
次要结局
- Areas of different perfusion density(6 months)
- Presence of predominantly peripheral lesions (PPL)(6 months)
- Retinal layer thickness(6 months)
- Foveal avascular zone (FAZ)(6 months)
- Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year(18 months)
研究者
Eduardo Navajas
Principal Investigator
University of British Columbia