search
Back to results

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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adjustable glasses
Custom standard glasses
Ready-made glasses
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myopia focused on measuring Myopia, self-refraction, glasses, spectacles

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

    Self-refraction with adjustable glasses

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

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

    Outcomes

    Primary Outcome Measures

    Wearing spectacles proportion
    The participators in each group may have the different wearing spectacles proportion.

    Secondary Outcome Measures

    The quality of life after wearing glasses(questionnaires)
    The quality of life will be learned by questionnaires

    Full Information

    First Posted
    August 16, 2015
    Last Updated
    October 10, 2018
    Sponsor
    Sun Yat-sen University
    Collaborators
    Gaozhou Hospital of Traditional Chinese Medicine, Xinyi traditional Chinese medicine hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02529540
    Brief Title
    WEAR (Wearability and Evaluation of Adjustable Refraction) III
    Acronym
    WEARIII
    Official Title
    WEAR (Wearability and Evaluation of Adjustable Refraction) III: A Randomized Non-inferiority Trial of Children's Wear of Adjustable Glasses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    June 1, 2016 (Actual)
    Study Completion Date
    June 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University
    Collaborators
    Gaozhou Hospital of Traditional Chinese Medicine, Xinyi traditional Chinese medicine hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    Myopia, self-refraction, glasses, spectacles

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    324 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Other
    Arm Description
    Self-refraction with adjustable glasses
    Arm Title
    Group 2
    Arm Type
    Other
    Arm Description
    Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses
    Arm Title
    Group 3
    Arm Type
    Other
    Arm Description
    Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses
    Intervention Type
    Other
    Intervention Name(s)
    Adjustable glasses
    Intervention Description
    The glasses will be used for refraction and wearing within professional instructions.
    Intervention Type
    Other
    Intervention Name(s)
    Custom standard glasses
    Intervention Description
    The custom standard glasses are made by the traditional standards after refraction.
    Intervention Type
    Other
    Intervention Name(s)
    Ready-made glasses
    Intervention Description
    The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.
    Primary Outcome Measure Information:
    Title
    Wearing spectacles proportion
    Description
    The participators in each group may have the different wearing spectacles proportion.
    Time Frame
    5 months after the start of the project
    Secondary Outcome Measure Information:
    Title
    The quality of life after wearing glasses(questionnaires)
    Description
    The quality of life will be learned by questionnaires
    Time Frame
    5 months after the start of the project
    Other Pre-specified Outcome Measures:
    Title
    Evaluation of the user's subjective impression（questionnaires）
    Description
    Evaluation of the user's subjective impression for the three type of glasses will be learned by questionnaires.
    Time Frame
    5 months after the start of the project
    Title
    Damaged condition of the glasses
    Description
    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.
    Time Frame
    5 months after the start of the project

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nathan Congdon, MD, MPH
    Organizational Affiliation
    The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14985292
    Citation
    He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
    Results Reference
    background
    PubMed Identifier
    19104465
    Citation
    He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.
    Results Reference
    background
    PubMed Identifier
    20547954
    Citation
    Li L, Lam J, Lu Y, Ye Y, Lam DS, Gao Y, Sharma A, Zhang M, Griffiths S, Congdon N. Attitudes of students, parents, and teachers toward glasses use in rural China. Arch Ophthalmol. 2010 Jun;128(6):759-65. doi: 10.1001/archophthalmol.2010.73.
    Results Reference
    background
    PubMed Identifier
    21232802
    Citation
    He M, Congdon N, MacKenzie G, Zeng Y, Silver JD, Ellwein L. The child self-refraction study results from urban Chinese children in Guangzhou. Ophthalmology. 2011 Jun;118(6):1162-9. doi: 10.1016/j.ophtha.2010.10.003. Epub 2011 Jan 12.
    Results Reference
    background
    PubMed Identifier
    24327616
    Citation
    Zhou Z, Zeng J, Ma X, Pang X, Yi H, Chen Q, Meltzer ME, He M, Rozelle S, Congdon N. Accuracy of rural refractionists in western China. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):154-61. doi: 10.1167/iovs.13-13250.
    Results Reference
    background
    PubMed Identifier
    31543351
    Citation
    Wang CY, Zhang G, Tang B, Jin L, Huang W, Wang X, Chen T, Zhu W, Xiao B, Wang J, Zhou Z, Tang Z, Liang Y, Crescioni M, Wilson D, McAneney H, Silver JD, Moore B, Congdon N. A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese Schoolchildren: Wearability and Evaluation of Adjustable Refraction III. Ophthalmology. 2020 Jan;127(1):27-37. doi: 10.1016/j.ophtha.2019.08.002. Epub 2019 Aug 14.
    Results Reference
    derived

    Learn more about this trial

    WEAR (Wearability and Evaluation of Adjustable Refraction) III

    We'll reach out to this number within 24 hrs