WEAR (Wearability and Evaluation of Adjustable Refraction) III

NCT02529540 | Completed

• 1 other identifier: ZOC-WEAR 3
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

Brief Summary

Two-month randomized trial comparing three groups.

Conditions

Myopia

Keywords

Myopia; self-refraction; glasses; spectacles

Outcome Measures

Primary Outcomes (1)

• Wearing spectacles proportion

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

  5 months after the start of the project

Secondary Outcomes (1)

• The quality of life after wearing glasses(questionnaires)

  5 months after the start of the project

Other Outcomes (2)

• Evaluation of the user's subjective impression（questionnaires）

  5 months after the start of the project

• Damaged condition of the glasses

  5 months after the start of the project

Study Arms (3)

Group 1

OTHER

Self-refraction with adjustable glasses

Other: Adjustable glasses

Group 2

OTHER

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

Other: Custom standard glasses

Group 3

OTHER

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

Other: Ready-made glasses

Interventions

Adjustable glasses OTHER

The glasses will be used for refraction and wearing within professional instructions.

Group 1

Custom standard glasses OTHER

The custom standard glasses are made by the traditional standards after refraction.

Group 2

Ready-made glasses OTHER

The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.

Group 3

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Gaozhou Hospital of Traditional Chinese Medicine: collaborator
• Xinyi traditional Chinese medicine hospital: collaborator

Related Publications (6)

• 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.

  PMID: 14985292 BACKGROUND

• 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.

  PMID: 19104465 BACKGROUND

• 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.

  PMID: 20547954 BACKGROUND

• 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.

  PMID: 21232802 BACKGROUND

• 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.

  PMID: 24327616 BACKGROUND

• 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.

  PMID: 31543351 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Nathan Congdon, MD, MPH

  The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD,MPH

Model Details: This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.

Study Record Dates

• First Submitted: August 16, 2015
• First Posted: August 20, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 15, 2018

Record last verified: 2018-10