Determine the Effects of Selenium and Melatonin on Ocular Ischemic Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- To determine the effects of selenium on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome
研究概览
简要总结
ABSTRACT:
PURPOSE: To determine the effects of selenium, melatonin and selenium + melatonin administered for one month on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome.
MATERIAL AND METHODS: Thirtyfive patients were included in the study. Study groups were formed as follows: 1-Control group, 2-Ischemia group 3-Selenium Ischemia group, 4-Melatonin Ischemia group, 5-Selenium + Melatonin + Ischemia group. AC samples were obtained. MDA and GSH levels in AC samples were evaluated.
RESULTS : MDA levels were significantly increased in ischemia groups. Selenium and melatonin supplementation resulted in reduction of MDA levels and significant increase in GSH values.
DISCUSSION: Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by selenium and melatonin supplementation.
KEYWORDS: Ocular ischemic syndrome, selenium, melatonin, MDA, GSH
详细描述
In this retroprospective study, patients who presented with the clinical features of OIS or who had a history of OIS and who had visited the Department of Ophthalmology or who were referred by the Department of Cardiology were considered for inclusion. The patients of OIS were included according to the following criteria (26-29) (1) when the stenosis of the ipsilateral (to the affected eye) internal carotid artery (ICA) was >50% and the ICA blood flow velocity was abnormal; (2) abnormal ocular symptoms and/or signs that could not be explained by other ocular diseases. The ocular symptoms included amaurosis fugax , visual loss ,floaters, metamorphopsia, phosphenes ,diplopia ,and ocular/periorbital pain . Most patients (88.10%) complained of constitutional symptoms, such as headache, syncope, palpitations, hemiplegia, and claudication.The patients who were suffered from other ocular diseases, including primary glaucoma, uveitis, age-related macular degeneration, symmetrical proliferative diabetic retinopathy, choroidal detachment, retinal detachment, hereditary eye diseases, ocular tumor, or ocular trauma, were excluded. Informed consent was acquired from all of the participants before the collection of clinical materials. The study adhered to the tenets of the Declaration of Helsinki.
All of the OIS patients underwent carotid artery color Doppler imaging (CDI) and/or computed tomographic angiography (CTA) to identify the ICA stenosis. Detailed ophthalmic examinations, including best-corrected visual acuity (BCVA), intraocular pressure (IOP), slit-lamp exam, and funduscopy were performed at each follow-up visit. Constitutional and ocular symptoms, medical history (arterial hypertension, diabetes mellitus (DM), hyperlipidemia (HLP), coronary heart disease, cerebrovascular disease, and so on), the clinical department of the first visit, and treatments were also recorded. A statistical description was generated using SPSS for Windows, version 22.0.
Twenty eight OIS patients were recruited in our study, including 20 males (%71,4) and 8 females (%28,6). The age of onset ranged from 58 to 87 years (65.10 ± 10.95), with the majority of patients aged between 61 and 75 years (69.50%). No statistically significant difference was found for gender and age between groups (p <0,01) The study was conducted at Trabzon Numune Training and Research Hospital between May 2014 and September 2016. Approval from the Trabzon Numune Training and Research Hospital Ethics Committee was obtained. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Patients were divided into five groups.
- Control group: Seven healty person were included in this group. After topical anesthesia approximately 0.1 cc samples were obtained from the anterior chamber.
- Ischemia group: Seven OIS patients were included in this group. Under topical anesthesia, 0.1 cc samples were obtained from the AC.
- Selenium + Ischemia group: Seven OIS patients were included in this group. The patients in this group were supplemented with oral selenium at 0.1mg/kg doses twice daily for one month. After selenium supplementation period was completed, AC sampling as described above.
- Melatonin + Ischemia group: Seven OIS patients were included in this group. The patients in this group were supplemented with oral melatonin 0.5 mg/kg/day doses twice daily for one month. After supplementation was completed 0.1 cc sampling from AC.
- Selenium + Melatonin + Ischemia group: Seven OIS patients were included in this group . The patients were supplemented with selenium and melatonin for one month as described above, subsequently 0.1 cc sampling from AC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 61 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients of Ocular ischemic syndrome (OIS) were the stenosis of the ipsilateral (to the affected eye) internal carotid artery (ICA) was >50%
- •The patients of Ocular ischemic syndrome (OIS) who the ICA blood flow velocity was abnormal;
- •Abnormal ocular symptoms and/or signs that could not be explained by other ocular diseases.
排除标准
- •The patients who were suffered from other ocular diseases( primary glaucoma, uveitis, age-related macular degeneration, symmetrical proliferative diabetic retinopathy, choroidal detachment, retinal detachment, hereditary eye diseases, ocular tumor, or ocular trauma)
研究组 & 干预措施
SELENIUM
The patients in this group were supplemented with oral selenium at 0.1mg/kg doses twice daily for one month. After selenium supplementation period was completed, AC sampling as described above.
干预措施: SELENIUM (Drug)
MELATONIN
The patients in this group were supplemented with oral melatonin 0.5 mg/kg/day doses twice daily for one month. After supplementation was completed 0.1 cc sampling from AC.
干预措施: MELATONIN (Drug)
结局指标
主要结局
To determine the effects of selenium on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome
时间窗: The patients were supplemented with oral selenium for one month.
The patients were supplemented with oral selenium at 0.1mg/kg doses twice daily for one month. After selenium supplementation period was completed, 0.1 cc samples were obtained from the anterior chamber (AC). And then determine AC Malondialdehyde (MDA) and Glutathione (GSH) levels.
To determine the effects of melatonin on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome
时间窗: The patients were supplemented with oral melatonin for one month.
The patients in this group were supplemented with oral melatonin 0.5 mg/kg/day doses twice daily for one month. After supplementation was completed 0.1 cc sampling from AC. And then determine AC Malondialdehyde (MDA) and Glutathione (GSH) levels.
次要结局
未报告次要终点
研究者
Hande Telek
Ophthalmology, MD,Principal Investigator
Beytepe Murat Erdi Eker State Hospital
