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Completed

NCT Number: NCT02529540

WEAR (Wearability and Evaluation of Adjustable Refraction) III

Two-month randomized trial comparing three groups.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjustable glasses

Other

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

Custom standard glasses

Other

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

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.

Primary outcomes

  1. Wearing spectacles proportion

    Time frame: 5 months after the start of the project

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

Secondary outcomes

  1. The quality of life after wearing glasses(questionnaires)

    Time frame: 5 months after the start of the project

    The quality of life will be learned by questionnaires

Other outcomes

  1. Evaluation of the user's subjective impression(questionnaires)

    Time frame: 5 months after the start of the project

    Evaluation of the user's subjective impression for the three type of glasses will be learned by questionnaires.

  2. Damaged condition of the glasses

    Time frame: 5 months after the start of the project

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Gaozhou Hospital of Traditional Chinese Medicine
  • Xinyi traditional Chinese medicine hospital

Registry information

Official study title

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

Acronym: WEARIII

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2015
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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