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
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, see Learn About Clinical Studies.

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:
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014