Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005222
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hande Telek, Beytepe Murat Erdi Eker State Hospital

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


Condition or disease Intervention/treatment Phase
Anterior Segment Ischemia (Diagnosis) Drug: SELENIUM Drug: MELATONIN Early Phase 1

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determine the Effects of Selenium and Melatonin on Ocular Ischemic Syndrome
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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.
Drug: SELENIUM
Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by selenium supplementation.
Other Name: MELATONIN

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.
Drug: MELATONIN
Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by melatonin supplementation.
Other Name: SELENIUM




Primary Outcome Measures :
  1. To determine the effects of selenium on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome [ Time Frame: 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.

  2. To determine the effects of melatonin on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   61 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Layout table for additonal information
Responsible Party: Hande Telek, Ophthalmology, MD,Principal Investigator, Beytepe Murat Erdi Eker State Hospital
ClinicalTrials.gov Identifier: NCT04005222     History of Changes
Other Study ID Numbers: BeytepeMuratErdiEkerSH
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hande Telek, Beytepe Murat Erdi Eker State Hospital:
Ocular ischemic syndrome
selenium
melatonin
MDA
GSH
Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Pathologic Processes
Selenium
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Trace Elements
Micronutrients
Nutrients
Growth Substances