A prospective, observational, longitudinal study to determine key factors in the onset and progression of myopia in children

Brien Holden Vision Institute0 sites109 target enrollmentNovember 26, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 26, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Observational

Sex

All

Sponsor

Brien Holden Vision Institute

•\* 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”.

•\* 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.