Myopia
Conditions
Keywords
Myopia, self-refraction, glasses, spectacles
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.
Interventions
OTHERAdjustable glasses
The glasses will be used for refraction and wearing within professional instructions.
OTHERCustom standard glasses
The custom standard glasses are made by the traditional standards after refraction.
OTHERReady-made glasses
The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.
Sponsors
Gaozhou Hospital of Traditional Chinese Medicine
Xinyi traditional Chinese medicine hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearing spectacles proportion | 5 months after the start of the project | The participators in each group may have the different wearing spectacles proportion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed