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

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

Two-month randomized trial comparing three groups.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Other: Adjustable glasses; Other: Custom standard glasses; Other: Ready-made glasses

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.

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Self-refraction with adjustable glasses	Other: Adjustable glasses; The glasses will be used for refraction and wearing within professional instructions.
Other: Group 2; 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.
Other: Group 3; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the user's subjective impression（questionnaires）	Evaluation of the user's subjective impression for the three type of glasses will be learned by questionnaires.	5 months after the start of the project
Damaged condition of the glasses	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.	5 months after the start of the project

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Gaozhou Hospital of Traditional Chinese Medicine; Xinyi traditional Chinese medicine hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 16, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Myopia; spectacles; glasses; self-refraction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: ZOC-WEAR 3