WEAR (Wearability and Evaluation of Adjustable Refraction) III

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Other: Custom standard glasses; Other: Adjustable glasses; Other: Ready-made glasses

• Registration Number: NCT02529540
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Two-month randomized trial comparing three groups.

Detailed Description

Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing three groups: self-refraction with adjustable glasses, receiving adjustable glasses; subjective refraction by an expert refractionist after computer optometry and receiving custom standard glasses; subjective refraction by an expert refractionist after computer optometry and receiving ready-made glasses. The main outcome of this study is the rate of glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher assessment of wearing study glasses will be calculated as the number of times wearing glasses/ Total number of separate observations.

Study Timeline

• Study First Submitted: 2015-08-16
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Study Start: 2015-09-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• 11-16 years old middle school students from two locations in Guangdong Province.
• With ≤ -1.00 Diopter of myopic refractive error in each eye.
• With uncorrected vision ≤ 6/12 in both eyes thought to be due to refractive error (that is, correctable to at least 6/7.5 with subjective refraction by an optometrist).
• With informed consents(There are two types of informed consents. One of them is whether the parents of the students agree their kids to participate in the project. The other informed consent is whether the parents agree their kids to have the cycloplegic refraction. If the students were admitted to participate in project but without being agreed to have cycloplegic refraction by their parents , they would have non cycloplegic retinoscopy.).

Exclusion Criteria

• Those corrected VA can not up to 6/7.5 with 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Custom standard glasses	Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses
Group 1	Adjustable glasses	Self-refraction with adjustable glasses
Group 3	Ready-made glasses	Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses

Primary Outcome Measures

Name	Time	Method
Wearing spectacles proportion	5 months after the start of the project	The participators in each group may have the different wearing spectacles proportion.

Secondary Outcome Measures

Name	Time	Method
The quality of life after wearing glasses(questionnaires)	5 months after the start of the project	The quality of life will be learned by questionnaires