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

Sun Yat-sen University

Status: Completed

Conditions: Myopia

Treatments: Other: Ready-made glasses; Other: Adjustable glasses; Other: Custom standard glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT02529540

ZOC-WEAR 3

Details and patient eligibility

About

Two-month randomized trial comparing three groups.

Full 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.

Enrollment: 324 patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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324 participants in 3 patient groups

Group 1

Other group

Description:

Self-refraction with adjustable glasses

Treatment:

Other: Adjustable glasses

Group 2

Other group

Description:

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

Treatment:

Other: Custom standard glasses

Group 3

Other group

Description:

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

Treatment:

Other: Ready-made glasses