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

The Effect of +3.00ADD on Myopia Progression in Chinese Children: A Cluster Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Device: two spectacles; Device: single vision spectacles

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 Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yet-san University
      • Contact: Yuting LI, Master; Phone Number: +86-020-87334687; Email: ytdorothy@163.com
      • Contact: Qianyun Chen, bachelor; Phone Number: +86-020-87334687; Email: torunchen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1. Children who are aged 8 to 12 years (grade 3 and grade 4) from Huadu district of Guangzhou in China.
2. 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.
3. The best corrected visual acuity is ≥ 6/9.5
4. 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

1. Children who are allergy to tropicamide or topical anesthetic drugs.
2. 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.
3. Children who were wearing rigid gas permeable contact lenses, progressive-addition lenses, bifocal spectacles lens, Peripheral defocus modifying contact lenses;
4. Children who are receiving visual function training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: two spectacles	Device: two spectacles; single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision
Active Comparator: single vision spectacles	Device: single vision spectacles; Wear single vision spectacle only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spherical equivalent refraction (SER) change	SE was measured by autorefractometer with cycloplegic once a year at scheduled time	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: +3.00ADD; single vision spectacle
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SYSU-OPH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No