Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Focal Electroretinogram Amplitude and Phase
研究概览
简要总结
This is a pilot interventional study whose aim is to determine the effect of a dietary supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.) indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal models of retinal degenerative disorders.The macular function will be tested by visual acuity and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a standardized technique (see citations).
详细描述
A group of 30 AMD patients with typical lesions (drusen and/or retinal pigment epithelial defects) and relatively preserved central retinal function and visual acuity will be enrolled. AMD patients will be randomly divided into two groups: 1. placebo group [n = 15), taking for three months an oral placebo; 2. Saffron group (n = 15), taking Saffron oral treatment (20 mg/day) for three months. After three months of placebo or Saffron supplementation, patients will be tested with standard ophthalmic examination and FERGs. Then, placebo with Saffron and vice-versa will be changed to the same patients in a cross-over design. After a further three month period of placebo or study drug supplementation, patients will undergo again a standard ophthalmic examination, and FERG. Throughout the study, both patients and experimenters will be masked as to the identity of pills (i.e. whether placebo or study drug), whose identification key number will be kept in a sealed envelope that will be opened only at the completion of the study. Therapeutic compliance will be tested by careful questioning, either at two weeks of treatment (by telephone interview) or at the end of the treatment period, as well as by pill count. Main outcome measures of the study will be FERG amplitude and phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Age > 55 yrs
- •Diagnosis of Early, non exudative AMD
- •Visual acuity of 20/40 or better
排除标准
- •Concomitant ocular or systemic disorders which may affect macular function
- •Drugs that may affect macular function
研究组 & 干预措施
Saffron
Crocus Sativus extract
干预措施: Saffron (Dietary Supplement)
Placebo
Placebo comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Focal Electroretinogram Amplitude and Phase
时间窗: 6 months
次要结局
- Visual Acuity(6 months)
研究者
Benedetto Falsini
Associate Professor, Ophthalmology
Catholic University of the Sacred Heart
