WEAR (Wearability and Evaluation of Adjustable Refraction) III (WEARIII)
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|ClinicalTrials.gov Identifier: NCT02529540|
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Other: Adjustable glasses Other: Custom standard glasses Other: Ready-made glasses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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 :||September 1, 2015|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||June 1, 2016|
Self-refraction with adjustable glasses
Other: Adjustable glasses
The glasses will be used for refraction and wearing within professional instructions.
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.
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.
- Wearing spectacles proportion [ Time Frame: 5 months after the start of the project ]The participators in each group may have the different wearing spectacles proportion.
- The quality of life after wearing glasses(questionnaires) [ Time Frame: 5 months after the start of the project ]The quality of life will be learned by questionnaires
- Evaluation of the user's subjective impression（questionnaires） [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529540
|Principal Investigator:||Nathan Congdon, MD, MPH||The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University|