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Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

Primary Purpose

Anterior Segment Ischemia (Diagnosis)

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
SELENIUM
MELATONIN
Sponsored by
Beytepe Murat Erdi Eker State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Segment Ischemia (Diagnosis) focused on measuring Ocular ischemic syndrome, selenium, melatonin, MDA, GSH

Eligibility Criteria

61 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    SELENIUM

    MELATONIN

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    To determine the effects of selenium on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2019
    Last Updated
    February 1, 2021
    Sponsor
    Beytepe Murat Erdi Eker State Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04005222
    Brief Title
    Effects of Selenium and Melatonin on Ocular Ischemic Syndrome
    Official Title
    Determine the Effects of Selenium and Melatonin on Ocular Ischemic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beytepe Murat Erdi Eker State Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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. In order to determine AC Malondialdehyde (MDA) levels, 2.5 ml of 10% TCA (tricholoroessigaurekrist.) was put in a test tube, 0.1 ml of AC sample from the patients was added. Tubes were vortexed and sealed. Incubation was applied for 15 minutes in 90ºC water bath. They were cooled in cold water and their absorbance values were read with reference to blank on spectrophotometer at 532 nm. Results were presented as nmol/ml. At the beginning of the testing, blank was prepared by placing the same amount of distilled water instead of plasma in the blank tube and performing the same procedures. In order to measure AC Glutathione (GSH) levels, AC samples placed in tubes containing EDTA were centrifuged at 3000 rpm for 5 minutes. The samples were washed 3 times with 0.9% saline solution and 50μl of each sample was derived. Consecutively, 450μl of distilled water and 500μl of 10% sulfosalicylic acid were added. The mixture was cooled in ice for 1 hour and then centrifuged at 4000 rev for 3 minutes. Subsequently, 200μl of the supernatant was derived and consecutively 8 ml of phosphate buffer with pH of 6.8, 78 μl of 1 N NaOH and 100μl of Ellman solution were added. After waiting for 5 minutes, absorbance values in reagent tube were read with reference to distilled water on spectrophotometer at 412 nm.Ellman solution was prepared by dissolving 100 mg of 5'-5'-dithiobis-2-nitrobenzoic acit (DTNB) in 100 ml of pH 7.8 phosphate buffer. Glutathione standard was prepared as 15.34mg/100 ml by dissolving 15.34 mg of reduced glutathione in 100 ml of 1 nm sodium EDTA. Results were presented as mg/dl.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Segment Ischemia (Diagnosis)
    Keywords
    Ocular ischemic syndrome, selenium, melatonin, MDA, GSH

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SELENIUM
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    MELATONIN
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    SELENIUM
    Other Intervention Name(s)
    MELATONIN
    Intervention Description
    Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by selenium supplementation.
    Intervention Type
    Drug
    Intervention Name(s)
    MELATONIN
    Other Intervention Name(s)
    SELENIUM
    Intervention Description
    Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by melatonin supplementation.
    Primary Outcome Measure Information:
    Title
    To determine the effects of selenium on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome
    Description
    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.
    Time Frame
    The patients were supplemented with oral selenium for one month.
    Title
    To determine the effects of melatonin on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome
    Description
    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.
    Time Frame
    The patients were supplemented with oral melatonin for one month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    61 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31886253
    Citation
    Telek HH. Effects of Selenium and Melatonin on Ocular Ischemic Syndrome. Biomed Res Int. 2019 Dec 6;2019:8080564. doi: 10.1155/2019/8080564. eCollection 2019.
    Results Reference
    derived

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    Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

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