Myopia Clinical Trial
Official title:
Association Between Breastfeeding and Likelihood of Myopia in 6-7 Years Old Children
Myopia is the main reason of vision loss in the world which is seen in 30.4 million adults
in USA (1). In a myopic eye, images are focused in front of retina because, cornea and
crystalline lens become more powerful in focusing the image or the eye axis become too long
(axial myopia) (2).
Myopia prevalence in adolescents has been raised in recent years and nowadays it has reached
to 10-25% and 60-80% in western and eastern countries respectively (3). Tehran eye study
showed that the prevalence of myopia in Tehran is 21.8% and 17.2% based on manifest and
cycloplegic refraction respectively (4). One study in Dezful, Iran showed that 3.7% of 7-15
years old children are myopic (5).
Today potential role of early life nutrition in myopia development in later life is becoming
an attractive field of study. It has been shown that until weaning; breast milk is the main
source of many nutrients [such as docosahexaenoic acid (DHA)] which are important for
photoreceptors and cortical neuronal development (6). But results about the relationship
between breastfeeding and likelihood of childhood myopia are controversial. A
hypothesis-generating study (7) showed an independent and inverse relationship between
breastfeeding and likelihood of myopia in 10-12 year old Singaporean children. However, data
pulled from three English birth cohorts done in 10-11y and 15-16y children did not show any
effect (8).
To examine the association between breastfeeding pattern and likelihood of myopia in 6-7y
children, a retrospective case-control study is designed in National Nutrition and Food
Technology research Institute of Iran. This study will try to assess breastfeeding pattern
and almost all cofactors which may relate to myopia.
For proper vision, eyes need to focus exactly on images. The two main determinants of
refraction are focus power of cornea and the eye's axis length. In normal eyes, images are
formed exactly on retina (emmetropia), but farsightedness (hyperopia) is the situation in
which, the eye forms images in the backside of retina and nearsightedness (myopia) is a
situation in which images are formed in front of retina, and it may have two reasons: 1) the
lens convexity is more powerful than normal and 2) the eye axis is longer than normal (axial
myopia).
Refractive errors are measured in diopter (D), and myopia is specified with a negative sign.
Severity of myopia is categorized into 3 levels. 1) Mild (0 to -1.5D), 2) moderate (-1.5D to
-6.0D) and 3) and severe myopia (-6.0D or above). Pathogenic myopia develops, when this
condition advances to -8.0 D and above. Visual disorders - moderate retina disorders,
cataract, and glaucoma - may be seen in patients with moderate and severe myopia. At birth,
most infants are hyperopic but this condition lowers when they grow up and by the age 5-8,
eyes must be emmetropic (normal and without any refractive error) (2).
Nearsightedness is seen in 30.4 million adults in USA (1). It's prevalence in adolescents is
remarkably increased in last decades and today its prevalence in industrialized western and
eastern societies are increased into 10-25 and 60-80 percent respectively (3). For American
society, 60 percent of myopia can be categorized as early myopia (in childhood/school ages)
which is usually in ages 9-11 years, and increases in adolescence years, and decreases in
late adolescence and beginning of 20th decade of life, and usually stops at -3 to -4
D(9,10). A study in Tehran (4) showed that prevalence of myopia is 21.8 and 56.6 percent
based on manifest and cycloplegic refraction respectively. Another study showed a high
prevalence of myopia in schoolchildren from Kashan, Iran (11). Also a study in Dezful, Iran
showed that prevalence of myopia in 7-15y and 14-18y children are 3.4 and 33 percent
respectively (12).
Factors related to myopia can be divided into two groups: 1) hereditary and 2)
environmental. Relationship between heredity and likelihood of myopia has been shown in many
studies (13, 14). These studies obviously showed the effect of parental myopia on moderate
levels of childhood myopia. Today different areas on several chromosomes are known for
severe myopia (such like 18p, 12q, 7q36, TGIF) (15-17). Although it seems that two of these
chromosomes (18q, 12q) do not have any relationship with childhood myopia (18).
Environmental factors which studies have shown that may be in relation with myopia are: near
work (19, 20), stature (21, 22), night time light exposure (10) [however this relationship
was not confirmed neither in American (20) and English children and nor in Indian monkeys
(23, 24)], day time light exposure (25), refined sugar consumption [It has been shown that
carbohydrate consumption can stimulate a series of events which lead to eye's axial length
increase and consequently myopia. So refined sugar consumption which has been increased
nowadays may play a role.] (26), IQ (Intelligence quotient) (27-33), birth weight, social
and economic condition (7), physical activity (32), and breastfeeding (7).
Increasing prevalence of myopia, particularly in Asian urban children, confirms that life
style in childhood and infancy may play a role (3). Today potential effect of early life
nutrition on myopia development in later life is becoming an attractive field of study.
Breastfeeding has been related to neural development which affects visual acuity. Up to
weaning, breastfeeding is the main source of many micronutrients [including docosahexanoic
acid (DHA)], which are important for light receptors and brain neural development (6). A
study which was done in Singapore showed that breastfeeding is independently related to
likelihood of myopia after controlling for cofactors (7). But this study had some
limitations which may affect the results. This study had a small population size and its
participants were from one school. All factors relating to myopia were not controlled by
this study. However, data pulled from three English birth cohorts done in 10-11y and 15-16y
children did not show any effect (8). Hence, results about the relationship between
breastfeeding and likelihood of childhood myopia are controversial.
To examine the association between breastfeeding pattern and likelihood of myopia in 6-7y
children, a retrospective case-control study is designed in National Nutrition and Food
Technology research Institute of Iran. This study will try to assess almost all cofactors
which may relate to myopia; such as child's age, sex, height, birth weight, maternal age at
delivery, IQ (intelligence quotient), near work, parental education and ethnicity, parental
myopia, child n-3(omega-3) fatty acid and refined carbohydrate intake, maternal n-3 fatty
acid intake, n-3 fatty acid intake while infancy, physical activity and other confounding
factors which may have an effect on the relationship among breastfeeding pattern and myopia.
;
Observational Model: Case Control, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04923841 -
Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine
|
N/A | |
Active, not recruiting |
NCT04080128 -
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
|
N/A | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Completed |
NCT04604405 -
Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
|
N/A | |
Recruiting |
NCT05594719 -
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
|
N/A | |
Completed |
NCT05594732 -
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
|
N/A | |
Completed |
NCT04492397 -
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
|
N/A | |
Completed |
NCT04536571 -
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
|
N/A | |
Completed |
NCT06046209 -
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
|
N/A | |
Recruiting |
NCT06344572 -
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
|
Phase 3 | |
Recruiting |
NCT05611294 -
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
|
N/A | |
Completed |
NCT05656885 -
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
|
N/A | |
Active, not recruiting |
NCT05534022 -
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.
|
N/A | |
Completed |
NCT03934788 -
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT03701516 -
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
|
N/A | |
Completed |
NCT05538754 -
Post-Market Evaluation of the EVO ICL
|
N/A | |
Completed |
NCT03139201 -
Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT02555722 -
Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
|
N/A | |
Not yet recruiting |
NCT06009458 -
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
|
N/A | |
Recruiting |
NCT05548478 -
Corneal Endothelial Cell Injury Induced by Mitomycin-C
|
N/A |