Myopia
Conditions
Interventions
1:Wear test lens (I) in one eye and a single vision contact lens in the contralateral eye. Lenses will be swapped (crossed-over) between the eyes at the end of the 6 month visit.
2:Wear test lens (II) in one eye and a single vision contact lens in the contralateral eye. Lenses will be swapped (crossed-over) between the eyes at the end of the 6 month visit.
Sponsors
Optometry Research Institute, Aier Eye Hospital Group
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Inclusion criteria
Inclusion criteria: Aged between 6 years to 15 years (6 years and 15 years inclusive); 1. At baseline, spherical component of refractive error -0.50 D to -2.00 D with cylinder no more than -0.75 D; spherical component of refractive error =2.00 D to -4.00 D with cylinder no more than -1.00D; anisometropia of = 0.75D 2. Give informed consent, and have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent by both parent / guardian and the participant; 3. be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 4. be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 5. have ocular health findings considered to be normal and which would not prevent the subject from safely wearing contact lenses; 6. have vision correctable to at least 6/9.5 or better in each eye with study contact lenses.
Exclusion criteria
Exclusion criteria: 1. pre-existing ocular irritation that would preclude contact lens fitting; 2. any systemic or ocular condition or ocular injury that may preclude safe wearing of contact lenses; 3. undergone corneal refractive surgery; 4. Keratoconus 5. a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics; 6. had strabismus and/or current ongoing amblyopia; 7. any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity; 8. current orthoptic treatment or vision training; 9. eye injury or surgery within 12 weeks immediately prior to enrolment for this trial; 10. undergone atropine treatment for myopia control; 11. worn bifocal or progressive addition spectacles or anti-myopia contact lenses previously; 12. worn orthokeratology lenses previously; 13. require anticholinergic medication for gastrointestinal or other conditions; 14. current enrolment in another clinical trial/research project. The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements (this may include the use or need of any ocular medication prior to or during the course of the trial, or any systemic medications prior to and needed during the trial that will affect ocular physiology or the performance of the lenses), or if it is believed to be in the subjects 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