WEAR (Wearability and Evaluation of Adjustable Refraction) III

Study Overview
=================
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.

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

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Other: Adjustable glasses
* Other: Custom standard glasses
* Other: Ready-made glasses


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Self-refraction with adjustable glasses | Other: Adjustable glasses<br>* The glasses will be used for refraction and wearing within professional instructions.<br>|
| Other: Group 2<br>Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses | Other: Custom standard glasses<br>* The custom standard glasses are made by the traditional standards after refraction.<br>|
| Other: Group 3<br>Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses | Other: Ready-made glasses<br>* The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing spectacles proportion | The participators in each group may have the different wearing spectacles proportion. | 5 months after the start of the project | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of life after wearing glasses(questionnaires) | The quality of life will be learned by questionnaires | 5 months after the start of the project | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, self-refraction, glasses, spectacles