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Clinical Trials/NCT02001415
NCT02001415
Unknown
Not Applicable

Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia

Peking University People's Hospital1 site in 1 country120 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Progressive Myopia
Sponsor
Peking University People's Hospital
Enrollment
120
Locations
1
Primary Endpoint
Change of Ocular Axial Length
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, & Myovision) on myopia control in Chinese adolescent patients.

Detailed Description

Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia). This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
September 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adolescent myopia patients
  • Myopic refraction between -1.00D and -4.50D
  • Astigmatism equal or less than -1.50D
  • Normal break up time of tear film (BUT \> 10s)

Exclusion Criteria

  • Existence of any ocular diseases except ametropia
  • Hyperopia
  • Severe dry eye

Outcomes

Primary Outcomes

Change of Ocular Axial Length

Time Frame: Baseline, 6 months, 12 months

Ocular axial length (AL), which increases with age, will be measured 3 times by an IOLMaster. The first AL examination was considered as the baseline data, and will be repeated 6 and 12 months later.

Secondary Outcomes

  • Change of Spherical Equivalent Refraction(Baseline, 6 months, 12 months)

Study Sites (1)

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