Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD
研究概览
简要总结
To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of progression in patients with age-related macular degeneration
详细描述
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly.[1] The disease is categorized into early, intermediate, or advanced stages based on the severity of symptoms. The advanced stage, including GA and CNV, involves central region of the retina, which leads to a gradual or rapid loss of photoreceptors and central vision.
The macular pigment (MP) consists of xanthophyll, which is formed from the yellow carotenoid lutein, zeaxanthin, and meso-zeaxanthin.These pigments play an important role in protecting the retina against oxidative stress through different mechanisms[6]. Many studies have shown a various association of AMD and MP.Blue Mountain Eye Study revealed low dietary intake of lutein and zeaxanthin is associated with a higher risk of AMD. However, dry and wet subtypes of AMD may have different etiologies and risk factors. Little is known whether longitudinal study of macular pigment optical density (MPOD) is related to AMD progression.
A comprehensive ophthalmologic examination including fundus photography,OCT and MPOD was performed at baseline, and semiannually thereafter for 3 years. Fundus reflectance (VISUCAM 500, reflectance of a single 460 nm wavelength) was used to measure the MPOD levels. Associated risk factors including body-mass index (BMI), smoking, diet, and cardiovascular diseases were documented. Drusen characteristics (size, type, area), pigmentary abnormalities (increased pigment, depigmentation, geographic atrophy), and presence of abnormalities characteristic of neovascular AMD were graded. For estimations of AMD progression , a 9-step severity scale that combines a 6-step drusen area scale with a 5-step pigmentary abnormality scale is used.
In this study, we are going to investigate a 3-year study of incidence and progression for AMD and associated risk factors, in a population-based cohort of Chinese aged 45 years and older living in the city of Wenzhou.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject is diagnosed with either CNV, dry AMD
- •45 years of age or older
- •provides signed and dated informed consent
排除标准
- •Ocular condition in the study eye which may impact vision and confound study outcomes
- •Presence of macular edema like retinal vascular diseases or diabetic retinopathy
- •active inflammation ofr infection in the study eye
- •high myopia（ ≥6D ）
结局指标
主要结局
Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD
时间窗: from baseline to month 36
Incident advanced AMD was evaluated based on the AMD grade at the end of the clinical trial with follow-up time of 3 years. Progressors were those individuals with early or intermediate AMD at baseline who progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progressed to advanced AMD in both eyes
次要结局
- Association between gender and incident Advanced AMD(baseline)
- Association between body mass index (BMI) and incident Advanced AMD(baseline)
- Association between Baseline AMD grade and incident Advanced AMD(baseline)
- Association between cigarette smoking and incident Advanced AMD(baseline)
- Association between age and incident Advanced AMD(baseline)
研究者
Xiaoling Liu
Chief in retina center
The Eye Hospital of Wenzhou Medical University