Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589128
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children a Randomized Double-blind Placebo-controlled Human Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DES
Brief Summary:
Computer vision syndrome CVS also referred to as Digital eye strain DES is a group of eye and vision problems caused by prolonged use of electronic devices The American Optometric Association APA defines DES as a group of eye and vision-related problems caused by prolonged computer tablet e-reader and cell phone use Currently for more than 20 years DES has been recognised as a public health issue and the terms DES are also used to describe the condition attributed to the wide range of digital devices associated with potential problems
Detailed Description:
Digital device usage has increased substantially in recent years across all age groups so that extensive daily use for both social and professional purposes is now normal Digital eye strain DES also known as computer vision syndrome encompasses a range of ocular and visual symptoms and estimates suggest its prevalence may be 50 or more among computer users Symptoms fall into two main categories those linked to accommodative or binocular vision stress and external symptoms linked to dry eye Although symptoms are typically transient they may be frequent and persistent and have an economic impact when vocational computer users are affected
Astaxanthin is a naturally occurring red carotenoid pigment belonging to the family of xanthophylls and is typically found in marine environments especially in microalgae and seafood such as salmonids shrimps and lobsters Application fields of astaxanthin range from the food coloring industry for its natural intense red color brightness to aquaculture and poultry industries for its natural feed addictive properties Due to its unique molecular structure astaxanthin features some important biologic properties mostly represented by strong antioxidant anti-inflammatory and antiapoptotic activities A growing body of evidence suggests that astaxanthin is efficacious in the prevention and treatment of several ocular diseases ranging from the anterior to the posterior pole of the eye In particular astaxanthin seems to be effective in improving blood capillary circulation of the eyes In Japan human clinical trial showed that consuming 9mg of astaxanthin daily over four weeks significantly improved the eyes ability to accommodate different focuses and reduce eye strain hazy vision flickering images shoulder or back stiffness as compared to the control group Astaxanthin has been reported to have an ocular accommodation improvement effect and acts as a substance to help with asthenopia recovery and could contribute to the improvement of blood circulation in peripheral systems Due to the well-known effects of helping 2 eyes in many ocular structures astaxanthin is a superlative bodyguard to prevent smartphone eye damages
DES is the most common eye problem associated with prolonged digital device use characterized by symptoms such as dry eyes itching foreign body sensation watering blurring of vision and headaches It is increasingly common for present day children have grown up with electronic devices and this has become the norm in many of the more affluent societies Some caregivers may even use such electronic technology as an electronic pacifier to calm and entertain their kids Digital technology always raises concerns about a potential negative impact on the physical cognitive emotion and social well-being of the children There is evidence that excessive screen time is associated with a variety of health harms among children with evidence strongest for an unhealthy diet adiposity depressive symptoms and quality of life
DES in children is of particular concerning as it does not have any suggested medical treatment to ameliorate the symptoms The role of nutrition as complementary medicine is getting scientific attention nowadays Astaxanthin a potent antioxidant classified under the red-pigment carotenoid is a promising vision enhancer with numerous human clinical trial evidences conducted among the adults However limited research has been conducted to determine the effect of astaxanthin supplementation among the children with DES As DES in children is of utmost concern the current study aims to investigate whether dietary supplementation with astaxanthin could 1 ameliorate the DES symptoms 2 improve the blue light exposure-associated health complaints 3 improve the cognitive function and quality of life among the school age children
Astaxanthin is a naturally occurring red carotenoid pigment belonging to the family of xanthophylls and is typically found in marine environments especially in microalgae and seafood such as salmonids shrimps and lobsters Application fields of astaxanthin range from the food coloring industry for its natural intense red color brightness to aquaculture and poultry industries for its natural feed addictive properties Due to its unique molecular structure astaxanthin features some important biologic properties mostly represented by strong antioxidant anti-inflammatory and antiapoptotic activities A growing body of evidence suggests that astaxanthin is efficacious in the prevention and treatment of several ocular diseases ranging from the anterior to the posterior pole of the eye In particular astaxanthin seems to be effective in improving blood capillary circulation of the eyes In Japan human clinical trial showed that consuming 9mg of astaxanthin daily over four weeks significantly improved the eyes ability to accommodate different focuses and reduce eye strain hazy vision flickering images shoulder or back stiffness as compared to the control group Astaxanthin has been reported to have an ocular accommodation improvement effect and acts as a substance to help with asthenopia recovery and could contribute to the improvement of blood circulation in peripheral systems Due to the well-known effects of helping 2 eyes in many ocular structures astaxanthin is a superlative bodyguard to prevent smartphone eye damages
DES is the most common eye problem associated with prolonged digital device use characterized by symptoms such as dry eyes itching foreign body sensation watering blurring of vision and headaches It is increasingly common for present day children have grown up with electronic devices and this has become the norm in many of the more affluent societies Some caregivers may even use such electronic technology as an electronic pacifier to calm and entertain their kids Digital technology always raises concerns about a potential negative impact on the physical cognitive emotion and social well-being of the children There is evidence that excessive screen time is associated with a variety of health harms among children with evidence strongest for an unhealthy diet adiposity depressive symptoms and quality of life
DES in children is of particular concerning as it does not have any suggested medical treatment to ameliorate the symptoms The role of nutrition as complementary medicine is getting scientific attention nowadays Astaxanthin a potent antioxidant classified under the red-pigment carotenoid is a promising vision enhancer with numerous human clinical trial evidences conducted among the adults However limited research has been conducted to determine the effect of astaxanthin supplementation among the children with DES As DES in children is of utmost concern the current study aims to investigate whether dietary supplementation with astaxanthin could 1 ameliorate the DES symptoms 2 improve the blue light exposure-associated health complaints 3 improve the cognitive function and quality of life among the school age children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None