The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure & Ocular Surface
2015年7月8日 更新者：University of Colorado, Denver
This study is designed with the intention to further elucidate the effects of omega-3 fatty acids on intraocular pressure (IOP) and signs/symptoms of dry eye.
Prior studies have shown statistically significant lowering of IOP with use of omega-3 fatty acids but have only been performed in animal models.
This study will be the first to attempt replication in human models.
A limited number of studies have shown an increase in tear production/volume as well as a decrease in the subjective symptoms of dry eye, but more studies are needed to better define these effects.
Better understanding of the effects of this supplement on intraocular pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies about new potential treatment options for these conditions.
研究概览
详细说明
The purpose of this research project is to determine the effects of omega-3 fatty acid supplementation on intraocular pressure (IOP) as well as the signs and symptoms of dry eye.
We hypothesize that dietary omega-3 fatty acid supplementation will be associated with a significant change in intraocular pressure compared to baseline measurements prior to beginning supplementation.
We further hypothesize that omega-3 fatty acid supplementation will be associated with a significant increase in tear production and volume as well as a significant change in patients' subjective complaints of dry eye.
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Eye Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 89年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog.
Age 40-89 of either gender, of any race/ethnicity
描述
Inclusion Criteria:
- Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog.
- Age 40-89 of either gender, of any race/ethnicity
Exclusion Criteria:
- Females who are currently pregnant or planning to become pregnant during the study period
- Age <40 years old
- Diagnosis of any other form of glaucoma other than open-angle
- Patients with known hypersensitivity (i.e., anaphylactic reaction) to omega-3 fatty acids or any of its components
- Patients with cirrhosis or with known liver disease
- Patients with diagnosed celiac disease
- Patients with a hypersensitivity to fish or shellfish
- Patients with paroxysmal or persistent atrial fibrillation
- Patients who are currently using medical or recreational marijuana
- Patients currently on any anticoagulation therapy including warfarin, dabigatran, apixaban, rivaroxaban, clopidogrel, cilostazol, dipyridamole, prasugrel, ticlopidine, ticagrelor
- Patients currently on Lovaza, an omega- 3 fatty acid supplement requiring a prescription
- Patients with any recent ocular surgery or laser treatment within 3 months
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure
大体时间：Change in intraocular pressure from baseline over 3 month
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Intraocular pressure is measured at the study start, and after three month on supplementation.
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Change in intraocular pressure from baseline over 3 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Effect of Omega-3 Fatty Acid Supplementation on Ocular Surface
大体时间：Change in Ocular Surface from baseline over 3 month
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Tear breakup time, corneal fluorescein staining, and tear osmolarity of Ocular Surface is measured at the study start, and after three month on supplementation
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Change in Ocular Surface from baseline over 3 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Leonard K Seibold, MD、University of Colorado, Denver
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年11月1日
初级完成 (预期的)
2015年11月1日
研究完成 (预期的)
2015年11月1日
研究注册日期
首次提交
2014年11月13日
首先提交符合 QC 标准的
2014年11月17日
首次发布 (估计)
2014年11月20日
研究记录更新
最后更新发布 (估计)
2015年7月9日
上次提交的符合 QC 标准的更新
2015年7月8日
最后验证
2015年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.