Myopia
Conditions
Interventions
Case series:None (observational study)
Sponsors
Optometry Research Institute, Aier Eye Hospital Group
Eligibility
Sex/Gender
All
Age
4 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Age in complete years ranging from 4 to 15 years, male or female. 2. Be, male or female 3. Vision of 20/40 or better with or without correction 4. In children -0.50 to +3.00D); astigmatism less than 1.50D in either eye 5. In children =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; 6. Have a parent or guardian who is able to read and comprehend English or Mandarin or Vietnamese or one of the Indian languages 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; 7. Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator; 8. Have ocular health findings considered to be normal.
Exclusion criteria
Exclusion criteria: 1. Have a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics; 2. Have undergone any pharmaceutical treatment for myopia control such as atropine or pirenzepine; 3. Is anisometropic by more than 1.50D; 4. Have strabismus and/or amblyopia; 5. Have worn orthokeratology lenses or myopia control contact lenses; 6. Have worn bifocal, progressive addition spectacles or Myovision spectacles; 7. 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; 8. Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjgrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; 9. Use of or a need for concurrent category S3 and above ocular medication at enrollment and/or during the clinical trial; 10. Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participants ocular health / physiology either in an adverse or beneficial manner at enrollment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an as needed basis, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used; 11. Eye surgery within 12 weeks immediately prior to enrollment for this trial; 12. Previous corneal refractive surgery; 13. Known allergy or intolerance to ingredients in any of the clinical trial products; 14. Currently enrolled in another clinical trial. The Investigator may, at his / her discretion, exclude anyone who they believe may not be able to fulfil the study requirements or it is believed to be in the participants best interests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spherical Equivalent ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial Length; | — |
Countries
China
Contacts
Public ContactYang Zhikuan
Optometry Research Institute, Aier Eye Hospital Group
Outcome results
None listed