The Effect of +3.00ADD on Myopia Progression in Chinese Children

Not Applicable

• Conditions: Myopia
• Interventions: Device: single vision spectacles; Device: two spectacles

• Registration Number: NCT03242226
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

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 spectacles for slowing the progression of myopia have been fully studied. Although some studies' results showed statistically significant for slowing myopia progression with multifocal spectacles, few had clinically meaningful, even in children with high accommodative lag or near-point esophoria. The investigators think that the possible reason for this clinical un-meaningful maybe that daily wearing bifocal or multifocal spectacles still not fully adjust the accommodative error in children.

The aim of this randomized clinical trial is to evaluate myopic progression in children using two spectacles (single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision), compared with control subjects wearing one spectacles (single-vision spectacles). Myopia progression quantified by changes in axial length (AL) and cycloplegic spherical equivalent refraction will be monitored for 3 years. The spectacles for intervention group children will be adjusted based on the cycloplegic spherical equivalent and the extent of accommodation lag for schedule time.

Study Timeline

• Study Start: 2016-10-11
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single vision spectacles	single vision spectacles	-
two spectacles	two spectacles	-

Primary Outcome Measures

Name	Time	Method
spherical equivalent refraction (SER) change	3 years	SE was measured by autorefractometer with cycloplegic once a year at scheduled time

Secondary Outcome Measures

Name	Time	Method
axial length	3 years	Axial length is measured by IOMaster once a year at scheduled time
corneal curvature	3 years	Corneal curvature is measured by IOMaster once a year at scheduled time
binocular vision	3 years	the binocular vision was measured by an ophthalmologist every six month at scheduled time.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yet-san University; 🇨🇳 Guangzhou, Guangdong, China