The Children's WEAR Trial(Phase 1&2)

Myopia Clinical Trial

— WEAR  

Official title:

The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704729
• Other study ID #: ZOC-WEAR-1
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: April 1, 2016

Study information

• Verified date: March 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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: self-refraction with adjustable glasses, receiving custom standard glasses; subjective refraction by an expert refractionist after cycloplegic automated refraction and receiving custom standard glasses; subjective refraction by a rural refractionist after cycloplegic automated refraction, receiving custom standard glasses; and subjective refraction by an expert refractionist after cycloplegic automated refraction receiving ready made glasses (September 2012 - August 2013)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: April 1, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Myopia

Intervention

Procedure:
• group1
Non-cycloplegic self-refraction +conventional glasses
• group2
Cycloplegic subjective refraction by experienced optometrist +conventional glasses
• group3
Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses
• group4
Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breakage, damage and loss of spectacles		2 months
Primary	Visual acuity with and without study refractive correction		2 months
Secondary	Self-reported and Supplemental visual functioning		2 months
Secondary	frequency of glasses-wear and the reason why the frequency is low		2 months
Secondary	Accuracy of spectacles given to children		2 months
Secondary	Value attached to the glasses and satisfaction to the glasses		2 months