The Effect of +3.00ADD on Myopia Progression in Chinese Children
1 other identifier
interventional
440
1 country
1
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 intervene the progression have been carried out based on the idea that myopia was caused by excessive accommodation, however, the effect was limited. The possible reason is that bifocal or multifocal spectacles still not fully adjust the accommodative error in myopia children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2016
CompletedFirst Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedSeptember 5, 2018
September 1, 2018
2.2 years
July 31, 2017
September 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
spherical equivalent refraction (SER) change
SE was measured by autorefractometer with cycloplegic once a year at scheduled time
3 years
Secondary Outcomes (3)
axial length
3 years
corneal curvature
3 years
binocular vision
3 years
Study Arms (2)
two spectacles
EXPERIMENTALsingle vision spectacles
ACTIVE COMPARATORInterventions
single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yet-san University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yizhi LIU, MD,PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
- STUDY DIRECTOR
Yangfa ZENG, MD,Master
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 8, 2017
Study Start
October 11, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
September 5, 2018
Record last verified: 2018-09