WEAR (Wearability and Evaluation of Adjustable Refraction) III

Sun Yat-sen University324 enrolled

Overview

Two-month randomized trial comparing three groups.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

324

Conditions

Myopia

Interventions

Adjustable glassesOTHER

The glasses will be used for refraction and wearing within professional instructions.

Custom standard glassesOTHER

The custom standard glasses are made by the traditional standards after refraction.

Ready-made glassesOTHER

The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Wearing spectacles proportion

The participators in each group may have the different wearing spectacles proportion.

Time frame: 5 months after the start of the project

Secondary Outcomes

The quality of life after wearing glasses(questionnaires)

The quality of life will be learned by questionnaires

Time frame: 5 months after the start of the project

Data from ClinicalTrials.gov

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