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Completed

NCT Number: NCT01704729

The Children's WEAR Trial(Phase 1&2)

Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: (September 2012 - August 2013)

Completed

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

About this study

Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: self-refraction with adjustable glasses, receiving custom standard glasses; subjective refraction by an expert refractionist after cycloplegic automated refraction and receiving custom standard glasses; subjective refraction by a rural refractionist after cycloplegic automated refraction, receiving custom standard glasses; and subjective refraction by an expert refractionist after cycloplegic automated refraction receiving ready made glasses (September 2012 - August 2013)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

phase1: - aged 12-17 years

  • with <= -1.00D of myopic refractive error in each eye phase2: - 12-15 years old children from two locations in Guangdong Province
  • with uncorrected vision </= 6/12 in at least one eye thought to be due to refractive error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction by an optometrist)

Exclusion criteria

  • those corrected VA can not up to 6/7.5 with cycloplegic 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

group1

Procedure

Non-cycloplegic self-refraction +conventional glasses

group2

Procedure

Cycloplegic subjective refraction by experienced optometrist +conventional glasses

group3

Procedure

Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses

group4

Procedure

Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses

Primary outcomes

  1. Visual acuity with and without study refractive correction

    Time frame: 2 months

Secondary outcomes

  1. Self-reported and Supplemental visual functioning

    Time frame: 2 months

  2. frequency of glasses-wear and the reason why the frequency is low

    Time frame: 2 months

  3. Accuracy of spectacles given to children

    Time frame: 2 months

  4. Value attached to the glasses and satisfaction to the glasses

    Time frame: 2 months

Other outcomes

  1. Breakage, damage and loss of spectacles

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)

Acronym: WEAR

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2012
Registry last updated
Mar 23, 2021

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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