Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02529540
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Gaozhou Hospital of Traditional Chinese Medicine
Xinyi traditional Chinese medicine hospital
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Brief Summary:
Two-month randomized trial comparing three groups.

Condition or disease Intervention/treatment Phase
Myopia Other: Adjustable glasses Other: Custom standard glasses Other: Ready-made glasses Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: WEAR (Wearability and Evaluation of Adjustable Refraction) III: A Randomized Non-inferiority Trial of Children's Wear of Adjustable Glasses
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Group 1
Self-refraction with adjustable glasses
Other: Adjustable glasses
The glasses will be used for refraction and wearing within professional instructions.

Group 2
Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses
Other: Custom standard glasses
The custom standard glasses are made by the traditional standards after refraction.

Group 3
Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses
Other: Ready-made glasses
The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529540


Sponsors and Collaborators
Sun Yat-sen University
Gaozhou Hospital of Traditional Chinese Medicine
Xinyi traditional Chinese medicine hospital
Investigators
Layout table for investigator information
Principal Investigator: Nathan Congdon, MD, MPH The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications:
Layout table for additonal information
Responsible Party: Congdon Nathan, Professor, MD,MPH, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02529540    
Other Study ID Numbers: ZOC-WEAR 3
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by Congdon Nathan, Sun Yat-sen University:
Myopia
self-refraction
glasses
spectacles
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors