ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01704729
Recruitment Status : Unknown
Verified October 2012 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Enrolling by invitation
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Myopia Procedure: group1 Procedure: group2 Procedure: group3 Procedure: group4 Phase 1 Phase 2

Detailed Description:
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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)
Study Start Date : September 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
group2
Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
Procedure: group2
Cycloplegic subjective refraction by experienced optometrist +conventional glasses
group3
Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program
Procedure: group3
Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses
group4
Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
Procedure: group4
Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses
group1
Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol
Procedure: group1
Non-cycloplegic self-refraction +conventional glasses



Primary Outcome Measures :
  1. Visual acuity with and without study refractive correction [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Breakage, damage and loss of spectacles [ Time Frame: 2 months ]


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.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01704729


Locations
China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Nathan G Congdon, MD,MPH Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University

Responsible Party: Congdon Nathan, MD,MPH, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01704729     History of Changes
Other Study ID Numbers: ZOC-WEAR-1
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Congdon Nathan, Sun Yat-sen University:
Myopia
Focus groups
refraction
Glasses
spectacles

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs