None listed
Conditions
Brief summary
The purpose of this study is to determine the risk factors related to progression of myopia in children aged 4 - 15 years by evaluating hereditary and environmental factors. The possible role of these newly found and existing factors in predicting the onset and progression of myopia in non-myopic eyes will also be determined. To achieve this, participants will be followed up for 2 years with 6 months interval. There will be a total of 5 to 6 visits for each participant. The null hypotheses of this study are; (i) Annual rate of myopia progression is age dependent. (ii) Onset and progression of myopia is dependent on the magnitude and intensity of near and outdoor activities
Interventions
This is a prospective, longitudinal, observational cohort study, where the eyes of 500 children aged 4 to 15 years will be monitored every 6 months for a total duration of two years. There will be 5 to 6 scheduled visits for each participant.
Every 6 months measurements such as height and weight, visual acuity, evaluation of anterior segment using slit lamp, accommodation, crystalline lens thickness and axial length measurements using Lenstar, posterior segment evaluation (retinal and choroidal
This is a prospective, longitudinal, observational cohort study, where the eyes of 500 children aged 4 to 15 years will be monitored every 6 months for a total duration of two years. There will be 5 to 6 scheduled visits for each participant. Every 6 months measurements such as height and weight, visual acuity, evaluation of anterior segment using slit lamp, accommodation, crystalline lens thickness and axial length measurements using Lenstar, posterior segment evaluation (retinal and choroidal thickness) using Optical Coherence Tomography (OCT) will be performed. In addition, participants will be dilated/cyclopleged and post cycloplegic measurements such as refractive error and crystalline lens power assessments will be performed. A minimum of 500 children from Australia, aged 4-15 years with both myopic and non-myopic refractive errors will be enrolled. To provide adequate number of new cases of pre-myopes and myopes and to establish association with risk factors and progression, children will be enrolled into age specific intervals. Once enrolled, they will be monitored every 6 months for a total duration of 2 years. Data from the study will be pooled from multi-sites following similar protocols. Collectively the data will be part of a prospective, longitudinal, observational cohort study with 3000 children (1400 Chinese, 550 Indian, 550 Vietnamese and 500 Australian children) aged 4 to 15 years with both myopic and non-myopic refractive errors enrolled.
Sponsors
Brien Holden Vision Institute
Eligibility
Sex/Gender
All
Age
4 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Age in complete years ranging from 4 to 15 years, male or female. * Vision of 20/40 or better with or without correction * In children <10 yrs of age: Cycloplegic spherical equivalent ranging from +3.00D to -4.00D (myopia- defined as having at least -0.50D to until -4.00D; non myopia more than-0.50 to +3.00D); astigmatism less than 1.50D in either eye * In children greater than or equal to 10 yrs of age: Cycloplegic spherical equivalent ranging from +3.00D to -5.50D (myopia- defined as having at least -0.50D to until -5.50D; non myopia >-0.50 to +3.00D); astigmatism less than 1.50D in either eye * Have a parent or guardian who is able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent and by the participant themselves if they are able to give their own consent. * Willing to comply with the wearing and study visit schedule as directed by the Investigator. * Have ocular health findings considered to be “normal”.
Exclusion criteria
* Have a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics; * Have undergone any pharmaceutical treatment for myopia control such as atropine or pirenzepine; * Is anisometropic by more than 1.50D; * Have strabismus and/or amblyopia; * Have been treated with orthokeratology lenses or myopia control contact lenses prior to enrolling in study; * Have been treated bifocal, progressive addition spectacles or Myovision spectacles prior to enrolling in study; * Any pre-existing condition with possible associations with myopia or affecting refractive development of the eye e.g. Marfan's syndrome, retinopathy of prematurity, diabetes; * Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. * Use of or a need for concurrent category S3 and above ocular medication at enrollment and/or during the study. * Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology either in an adverse or beneficial manner at enrollment and/or during the study. * Eye surgery within 12 weeks immediately prior to enrollment for this study. * Previous corneal refractive surgery. * Currently enrolled in another clinical trial.
Outcome results
None listed