MyopiaNCT01013493
Association Between Breastfeeding and Likelihood of Myopia in 6-7 Years Old Children
An observational study of Myopia and Nearsightedness, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Nearsightedness
- How many people
- 245 participants
- Where
- 1 siteIran
- Study dates
- Sep 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study is a retrospective case-control trial, in which subjects for case and control groups will be chosen based on inclusion and exclusion criteria, from 6-7 years old school children living in north Tehran.
Who may be able to join
- Subjects must be 6-7 years old
- Subjects must have myopia with or without astigmatism and the time period between diagnosis of myopia and recruiting the subjects must not be more than 6 months.
- Subject must be graduating in grade 1 in one of north Tehran elementary schools.
- Subject and their parents must have tendency to participate in this study.
- Subjects must be 6-7 years old
- Subjects must graduate in grade, class and elementary school which case subjects is graduating in.
Who cannot join
- Subjects must not have any eye disorder other than myopia with or without astigmatism
- Subjects must not have any metabolic or congenital disorder which has relationship with myopia.
- Subjects must not have any eye disorder
- Subjects must not have any metabolic or congenital disorder which has relationship with myopia.
- Subjects must not go on diet for any reason.
Trial locations and contacts
1 site in 1 country.
Iran1 site
National Nutrition and Food Technology Research Institute (NNFTRI)
Tehran, Tehran Province, 1981619573
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Myopia, Nearsightedness
- Keywords
- breastfeeding, myopia, nearsightedness, children
- Medical subject headings
- Myopia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| myopic | Not described | |
| non myope-healthy | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Investigators
- Amin Salehi Abargouei, M.S, Principal investigator, Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, IranNaser Kalantari, Pediatrist, Study chair, Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013493
- Sponsor's protocol ID
- 292
- Status last verified
- Dec 2009
- First submitted
- 12 Nov 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Breastfeeding and Likelihood of Myopia in 6-7 Years Old Children
- ClinicalTrials.gov ID
- NCT01013493
- Acronym / sponsor ID
- 292
- Conditions
- Myopia, Nearsightedness
- Keywords
- breastfeeding, myopia, nearsightedness, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myopic | – | – |
| non myope-healthy | – | – |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study is a retrospective case-control trial, in which subjects for case and control groups will be chosen based on inclusion and exclusion criteria, from 6-7 years old school children living in north Tehran.
Key inclusion criteria (6 listed)
- Subjects must be 6-7 years old
- Subjects must have myopia with or without astigmatism and the time period between diagnosis of myopia and recruiting the subjects must not be more than 6 months.
- Subject must be graduating in grade 1 in one of north Tehran elementary schools.
- Subject and their parents must have tendency to participate in this study.
- Subjects must be 6-7 years old
Key exclusion criteria (5 listed)
- Subjects must not have any eye disorder other than myopia with or without astigmatism
- Subjects must not have any metabolic or congenital disorder which has relationship with myopia.
- Subjects must not have any eye disorder
- Subjects must not have any metabolic or congenital disorder which has relationship with myopia.
- Subjects must not go on diet for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin Salehi Abargouei, M.S principal investigator
Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran
Naser Kalantari, Pediatrist study chair
Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Nearsightedness, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.