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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01704729
First received: September 20, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Myopia
Procedure: group1
Procedure: group2
Procedure: group3
Procedure: group4
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Visual acuity with and without study refractive correction [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported and Supplemental visual functioning [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • frequency of glasses-wear and the reason why the frequency is low [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Accuracy of spectacles given to children [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Value attached to the glasses and satisfaction to the glasses [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Breakage, damage and loss of spectacles [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2300
Study Start Date: September 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Congdon Nathan, MD,MPH, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01704729     History of Changes
Other Study ID Numbers: ZOC-WEAR-1
Study First Received: September 20, 2012
Last Updated: October 10, 2012
Health Authority: China: Ministry of Science and Technology

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014