Status:
UNKNOWN
The Effect of +3.00ADD on Myopia Progression in Chinese Children
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Myopia
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on the progression of myopia in children. Many studies applying bifocals or multifocal spectacles to interven...
Detailed Description
The optical intervention has been extensively explored for the intervention of myopia progression. Based on the theory that myopia was caused by the excessive accommodative, bifocal or multifocal spe...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Children who are aged 8 to 12 years (grade 3 and grade 4) from Huadu district of Guangzhou in China.
- Refractive error meeting all the following, obtained by cycloplegic autorefraction: spherical equivalent -1.00 to -6.00D in both eyes, astigmatism ≤2.00 D in both eyes, and spherical equivalent anisometropia ≤1.50 D.
- The best corrected visual acuity is ≥ 6/9.5
- The parents are willing to provide consent to participation in the study, and the children are willing to wear the only provided spectacles
- Exclusion criteria
- Children who are allergy to tropicamide or topical anesthetic drugs.
- Children who had other eye diseases that cause the visual impairment including strabismus, amblyopia, ocular surface related disease, cataract, traumas, ocular fundus diseases, and ocular surgery.
- Children who were wearing rigid gas permeable contact lenses, progressive-addition lenses, bifocal spectacles lens, Peripheral defocus modifying contact lenses;
- Children who are receiving visual function training.
Exclusion
Key Trial Info
Start Date :
October 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT03242226
Start Date
October 11 2016
End Date
December 31 2018
Last Update
September 5 2018
Active Locations (1)
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1
Zhongshan Ophthalmic Center, Sun Yet-san University
Guangzhou, Guangdong, China, 510000