WEARIII: WEAR (Wearability and Evaluation of Adjustable Refraction) III

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02529540

Collaborator

Gaozhou Hospital of Traditional Chinese Medicine (Other), Xinyi traditional Chinese medicine hospital (Other)

324

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Two-month randomized trial comparing three groups.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Other: Adjustable glasses Other: Custom standard glasses Other: Ready-made glasses	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

WEAR (Wearability and Evaluation of Adjustable Refraction) III: A Randomized Non-inferiority Trial of Children's Wear of Adjustable Glasses

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1 Self-refraction with adjustable glasses	Other: Adjustable glasses The glasses will be used for refraction and wearing within professional instructions.
Other: Group 2 Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses	Other: Custom standard glasses The custom standard glasses are made by the traditional standards after refraction.
Other: Group 3 Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses	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.

Arm

Intervention/Treatment

Other: Group 1

Self-refraction with adjustable glasses

Other: Adjustable glasses

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

Other: Group 2

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

Other: Custom standard glasses

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

Other: Group 3

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

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.

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Evaluation of the user's subjective impression（questionnaires） [5 months after the start of the project]
Evaluation of the user's subjective impression for the three type of glasses will be learned by questionnaires.
Damaged condition of the glasses [5 months after the start of the project]
The glasses may be damaged during use. At the end of project, every user will have have a questionnaire about damaged condition of glasses, such as missing screws, having scratches on the surface of lens and so on.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.