Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

NCT04005222 | Completed Early Phase 1

• 1 other identifier: BeytepeMuratErdiEkerSH
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anterior Segment Ischemia (Diagnosis)

Keywords

Ocular ischemic syndrome; selenium; melatonin; MDA; GSH

Outcome Measures

Primary Outcomes (2)

• 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.

  The patients were supplemented with oral selenium for one month.

• 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.

  The patients were supplemented with oral melatonin for one month.

Study Arms (2)

SELENIUM

OTHER

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

MELATONIN

OTHER

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

Interventions

SELENIUM DRUG

Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by selenium supplementation.

Also known as: MELATONIN

SELENIUM

MELATONIN DRUG

Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by melatonin supplementation.

Also known as: SELENIUM

MELATONIN

Eligibility Criteria

• Age: 61 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beytepe Murat Erdi Eker State Hospital: lead

Related Publications (1)

• 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.

  PMID: 31886253 DERIVED

MeSH Terms

Conditions

Disease

Interventions

Selenium; Melatonin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology, MD,Principal Investigator

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 2, 2019
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 3, 2021

Record last verified: 2021-02