Clinical trial NCT02529540: WEAR (Wearability and Evaluation of Adjustable Refraction) III
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
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia
self-refraction
glasses
spectacles
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Gaozhou Hospital of Traditional Chinese Medicine
name: Xinyi traditional Chinese medicine hospital
First posted: 2015-08-20
Enrollment: 324
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Wearing spectacles proportion
timeFrame: 5 months after the start of the project
Secondary outcomes:
measure: The quality of life after wearing glasses(questionnaires)
timeFrame: 5 months after the start of the project
Other outcomes:
measure: Evaluation of the user's subjective impression（questionnaires）
timeFrame: 5 months after the start of the project
measure: Damaged condition of the glasses
timeFrame: 5 months after the start of the project
Locations:
Study officials:
affiliation: The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Nathan Congdon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.