Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Affordance
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Comparative analysis of macular pigment density
研究概览
简要总结
•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits.
•Primary outcome:
Comparative analysis of the density and evolution of the density of macular pigment:
-
In patients without any retinal pathology who underwent cataract surgery 1 month previously
-
In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye
-
Secondary outcomes:
Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):
-
Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
-
Time taken to return to the baseline macular pigment density after cessation of supplementation
-
Study design :
Pilot study -Prospective, randomised, double-masked, comparative, multicenter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders (male or female), ≥ 55 years of age.
- •Patients without any retinal pathology who underwent cataract surgery 1 month previously Or
- •Patients with neovascular AMD (Age-related macular Degeneration) in one eye.
- •Patients who gave their written consent
排除标准
- •Exclusion criteria related to the study:
- •Intolerance to the tested product
- •Change in fundus image
- •Patients already taking Nutrof Total or similar supplements containing Lutein and Zeaxanthin
- •Allergy to mydriatics
- •Exclusion criteria for ophthalmologic reasons:
- •o Ocular diseases or conditions whose presence might interfere with the measurement of optical density of macular pigment (e.g. cataract, diabetic retinopathy, optic atrophy, myopia> -6.5 Diopters)
- •Exclusion criteria for systemic reasons:
- •o Medical or surgical history, disorder or disease (e.g. severe organic disease, acute or chronic: liver disease, endocrine, neoplastic, hematologic, infectious diseases, severe psychiatric disorder, significant cardiovascular abnormalities, etc...) and / or aggravating factors or structural defect, considered as being inconsistent with the study by the investigator.
- •Exclusion criteria for general reasons:
- •Inability of the patient to understand the study procedures and to give informed consent.
- •Ward of court
- •Patient not covered by the social security scheme
- •Pregnancy
结局指标
主要结局
Comparative analysis of macular pigment density
时间窗: 18 months
Comparative analysis of macular pigment density in patients who underwent cataract operation 1 month ago, without retinal pathology and in patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye. Optical density (OD)parameters of the macular pigments measured by an objective reflectometry method based on a 30° field image acquired by the Visucam 200 or 500 of Zeiss : Area : where macular pigments could be detected Max OD/Mean OD/ Volume : Maximum value/Mean Value/Sum of all OD in the area
次要结局
- Analysis of changes in macular pigment density(18 months)