NCT02260973Unknown2 期
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.
Physician Recommended Nutriceuticals4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Visual Acuity
研究概览
简要总结
This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of nuclear or cortical lens opacities in one/both eyes
- •Physician diagnosis of age related cataract
- •Good overall physical constitution
- •All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)
排除标准
- •Subjects requiring Premium IOLs/multifocal implants
- •Advanced cataract
- •Severe Age-Related Macular Degeneration Presence or history of Glaucoma
- •Presence or history of Diabetes Mellitus
- •Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
- •Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion
- •Vision loss due to presence of large pituitary tumors or aneurysms
- •Vision loss due to optic tract lesions
- •Vision loss due to bleeding into aqueous or vitreous chamber
- •Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen
- •Major cardiovascular or cerebral events in the past 12 months
- •Allergy to fish oil or safflower oil
- •Pregnancy or lactation at any time during the study
- •Newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
- •Participation in any other study involving an investigational drug or device within the past 30 days
结局指标
主要结局
Visual Acuity
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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