NCT01704729

Brief Summary

Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: (September 2012 - August 2013)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

September 20, 2012

Last Update Submit

March 18, 2021

Conditions

Myopia

Keywords

MyopiaFocus groupsrefractionGlassesspectacles

Outcome Measures

Primary Outcomes (1)

  • Visual acuity with and without study refractive correction

    2 months

Secondary Outcomes (4)

  • Self-reported and Supplemental visual functioning

    2 months

  • frequency of glasses-wear and the reason why the frequency is low

    2 months

  • Accuracy of spectacles given to children

    2 months

  • Value attached to the glasses and satisfaction to the glasses

    2 months

Other Outcomes (1)

  • Breakage, damage and loss of spectacles

    2 months

Study Arms (4)

group2

OTHER

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

Procedure: group2

group3

OTHER

Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program

Procedure: group3

group4

OTHER

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

Procedure: group4

group1

OTHER

Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol

Procedure: group1

Interventions

group1PROCEDURE

Non-cycloplegic self-refraction +conventional glasses

group1
group2PROCEDURE

Cycloplegic subjective refraction by experienced optometrist +conventional glasses

group2
group3PROCEDURE

Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses

group3
group4PROCEDURE

Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses

group4

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • phase1: - aged 12-17 years
  • with \<= -1.00D of myopic refractive error in each eye phase2: - 12-15 years old children from two locations in Guangdong Province
  • with uncorrected vision \</= 6/12 in at least one eye thought to be due to refractive error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction by an optometrist)

You may not qualify if:

  • those corrected VA can not up to 6/7.5 with cycloplegic subjective refraction by an optometrist
  • those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded.
  • Children developing acquired vision problems other than myopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Myopia

Interventions

XRCC4 protein, Arabidopsis

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Nathan G Congdon, MD,MPH

    Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,MPH

Study Record Dates

First Submitted

September 20, 2012

First Posted

October 11, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

CN(1)