WEAR (Wearability and Evaluation of Adjustable Refraction) III

Myopia Clinical Trial

— WEARIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529540
• Other study ID #: ZOC-WEAR 3
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: October 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two-month randomized trial comparing three groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Adjustable glasses
The glasses will be used for refraction and wearing within professional instructions.
• Custom standard glasses
The custom standard glasses are made by the traditional standards after refraction.
• Ready-made glasses
The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Gaozhou traditional Chinese medicine hospital, Xinyi traditional Chinese medicine hospital

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Wearing spectacles proportion	The participators in each group may have the different wearing spectacles proportion.	5 months after the start of the project
Secondary	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