Refractive Error
Conditions
Interventions
Group 1:Conventional Spherical Contact Lens, daily wear
Group 2:contact lenses, daily wear
Group 3:contact lenses, daily wear
Group 4:contact lenses, daily wear
Sponsors
Zhongshan Ophthalmic Centre
Eligibility
Sex/Gender
Male
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. be accompanied by 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; 2. at baseline, be within the age range of 6 to 14 years old inclusive; 3. be of Chinese ethnicity 4. at baseline, be myopic (short-sighted) up to -3.50 D of spherical equivalent with no more than 0.75 D; 5. be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 6. have ocular health findings considered to be "normal" and which would not prevent the subject from safely wearing contact lenses; 7. have vision correctable to at least 6/9 (20/30) or better in each eye with contact lenses; 8. be experienced or may be inexperienced at wearing 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. ethnicity other than Chinese; 6. a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 7. astigmatism more than 0.75 D in either eye; 8. had strabismus and/or amblyopia; 9. any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity; 10. current orthoptic treatment or vision training; 11. eye injury or surgery within 12 weeks immediately prior to enrolment for this trial; 12. undergone atropine treatment for myopia control; 13. worn bifocal or progressive addition spectacles in the previous 12 months; 14. worn orthokeratology lenses in the previous 12 months; 15. require anticholinergic medication for gastrointestinal or other conditions; 16. be anisometropic by more than 1.50D; 17. pregnant or lactating females (as reported by subject or their parent/guardian); 18. current enrolment in another clinical trial/research project; 19. 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 use of any ocular or S3 type medication prior to or needed during the course of the trial, or any systemic medications prior to and during the trial that will affect ocular physiology or the performance of the lenses), or if it is believed to be in the subject’s best interests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cycloplegic refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular axial length; | — |
Countries
China
Contacts
Public ContactXiang Chen
Outcome results
None listed