Effect of Krill Oil Supplementation on Dry Age-Related Macular Degeneration: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Macular Drusen Volume
研究概览
简要总结
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of krill oil supplementation in patients with dry age-related macular degeneration (AMD). Participants will receive 4 capsules of krill oil or placebo daily for a period of 3 months. Outcomes will be evaluated after 3-month treatment to assess differences between the two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults diagnosed with dry AMD at an early or intermediate stage, classified according to the Beckman Classification and confirmed by fundus photography: (1) Early AMD: medium drusen (>63 μm and ≤125 μm) without AMD-related pigmentary abnormalities; (2) Intermediate AMD: large drusen (>125 μm), with or without AMD-related pigmentary abnormalities.
- •Willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin.
- •Willing to sign the informed consent, and willing to attend follow-up visits for at least 3 months.
排除标准
- •Any eye with disease that would interfere with the fundus examinations.
- •Eye with choroidal neovascularization (CNV), geographic atrophy (GA), or high myopia.
- •Surgeries that may interfere with AMD evaluation.
- •Long-term use of any medications that are associated with retinal or neural toxicities.
- •History of supplementation with lutein, zeaxanthin, DHA, or EPA, unless a wash-out period of at least 8 weeks is completed prior to enrollment.
- •Intraocular pressure more than 26 mmHg.
- •Received cataract surgery in 3 months.
- •Other conditions: subjects with severe systemic diseases; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
- •Other conditions not suitable for the current study.
结局指标
主要结局
Change in Macular Drusen Volume
时间窗: From enrollment to the end of follow-up at 3 months.
Macular drusen volume will be quantified using spectral-domain optical coherence tomography (SD-OCT). Automated segmentation of Bruch's membrane and the retinal pigment epithelium (RPE), followed by manual verification, will be performed to calculate drusen volume at baseline and after 3 months of intervention at the same retinal location. Change in macular drusen volume will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline drusen volume divided by the baseline drusen volume.
次要结局
- Change in Maximum Macular Drusen Height(From enrollment to the end of follow-up at 3 months.)
- Change in Best-Corrected Visual Acuity(From enrollment to the end of follow-up at 3 months.)
- Change in Self-Reported Visual Function(From enrollment to the end of follow-up at 3 months.)
研究者
Xiaodong Sun
Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine