WEAR (Wearability and Evaluation of Adjustable Refraction) III

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-06-01

Brief Summary

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Two-month randomized trial comparing three groups.

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group 1

Self-refraction with adjustable glasses

Group Type OTHER

Adjustable glasses

Intervention Type OTHER

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

Group 2

Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses

Group Type OTHER

Custom standard glasses

Intervention Type OTHER

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

Group 3

Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses

Group Type OTHER

Ready-made glasses

Intervention Type OTHER

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

Interventions

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Adjustable glasses

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

Intervention Type OTHER

Custom standard glasses

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

Intervention Type OTHER

Ready-made glasses

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No