Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04005222
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2019-06-24
Brief Title:
Effects of Selenium and Melatonin on Ocular Ischemic Syndrome
Sponsor:
Beytepe Murat Erdi Eker State Hospital
Organization:
Beytepe Murat Erdi Eker State Hospital
Study Overview
Official Title:
Determine the Effects of Selenium and Melatonin on Ocular Ischemic Syndrome
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor signs that could not be explained by other ocular diseases The ocular symptoms included amaurosis fugax visual loss floaters metamorphopsia phosphenes diplopia and ocularperiorbital pain Most patients 8810 complained of constitutional symptoms such as headache syncope palpitations hemiplegia and claudicationThe 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 andor 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 220
Twenty eight OIS patients were recruited in our study including 20 males 714 and 8 females 286 The age of onset ranged from 58 to 87 years 6510 1095 with the majority of patients aged between 61 and 75 years 6950 No statistically significant difference was found for gender and age between groups p 001 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 andor national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards
Patients were divided into five groups
1 Control group Seven healty person were included in this group After topical anesthesia approximately 01 cc samples were obtained from the anterior chamber
2 Ischemia group Seven OIS patients were included in this group Under topical anesthesia 01 cc samples were obtained from the AC
3 Selenium Ischemia group Seven OIS patients were included in this group The patients in this group were supplemented with oral selenium at 01mgkg doses twice daily for one month After selenium supplementation period was completed AC sampling as described above
4 Melatonin Ischemia group Seven OIS patients were included in this group The patients in this group were supplemented with oral melatonin 05 mgkgday doses twice daily for one month After supplementation was completed 01 cc sampling from AC
5 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 01 cc sampling from AC
In order to determine AC Malondialdehyde MDA levels 25 ml of 10 TCA tricholoroessigaurekrist was put in a test tube 01 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 nmolml 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 09 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 68 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 nmEllman solution was prepared by dissolving 100 mg of 5-5-dithiobis-2-nitrobenzoic acit DTNB in 100 ml of pH 78 phosphate buffer Glutathione standard was prepared as 1534mg100 ml by dissolving 1534 mg of reduced glutathione in 100 ml of 1 nm sodium EDTA Results were presented as mgdl
All of the OIS patients underwent carotid artery color Doppler imaging CDI andor 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 220
Twenty eight OIS patients were recruited in our study including 20 males 714 and 8 females 286 The age of onset ranged from 58 to 87 years 6510 1095 with the majority of patients aged between 61 and 75 years 6950 No statistically significant difference was found for gender and age between groups p 001 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 andor national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards
Patients were divided into five groups
1 Control group Seven healty person were included in this group After topical anesthesia approximately 01 cc samples were obtained from the anterior chamber
2 Ischemia group Seven OIS patients were included in this group Under topical anesthesia 01 cc samples were obtained from the AC
3 Selenium Ischemia group Seven OIS patients were included in this group The patients in this group were supplemented with oral selenium at 01mgkg doses twice daily for one month After selenium supplementation period was completed AC sampling as described above
4 Melatonin Ischemia group Seven OIS patients were included in this group The patients in this group were supplemented with oral melatonin 05 mgkgday doses twice daily for one month After supplementation was completed 01 cc sampling from AC
5 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 01 cc sampling from AC
In order to determine AC Malondialdehyde MDA levels 25 ml of 10 TCA tricholoroessigaurekrist was put in a test tube 01 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 nmolml 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 09 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 68 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 nmEllman solution was prepared by dissolving 100 mg of 5-5-dithiobis-2-nitrobenzoic acit DTNB in 100 ml of pH 78 phosphate buffer Glutathione standard was prepared as 1534mg100 ml by dissolving 1534 mg of reduced glutathione in 100 ml of 1 nm sodium EDTA Results were presented as mgdl
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None