Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia (DLTCAM)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia|
- Change of Ocular Axial Length [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]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.
- Change of Spherical Equivalent Refraction [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]Spherical Equivalent Refraction (SER), which usually changes from time to time, will be measured 3 times by an open field auto-refractometer. The first SER examination was considered as the baseline data, and will be repeated 6 and 12 months later.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Spectacles
Spectacles are the most common lens treatment to correct myopia. This arm is set to be as a control group for the other two arms. Myopia patients who enter in this group will wear a normal pair of glasses after the baseline examinations (axial length, refraction...).
Normal spectacle lenses were used to correct myopia as the control group.
Active Comparator: Myovison
Myovision is a kind of specially designed, commercially available spectacle lenses that could control the peripheral refraction of myopia patients. Latest studies have changed the understanding of myopia--correcting both central and peripheral vision during lens treatment is indicating to be an effective way of slowing down eye growth. Patients who entered this group will wear a pair of Myovision after baseline examinations.
Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.
Active Comparator: Ortho-K
Orthokeratology has recently been reported as an effective way to control eye growth for myopia adolescents. Patents who enter this group will wear ortho-K lenses during sleep after baseline examinations.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001415
|Contact: Kai Wang, Dr.||+firstname.lastname@example.org|
|Contact: Xi Rong Wu, Dr.|
|Ophthalmology Department of Peking University People's Hospital||Recruiting|
|Beijing, China, 100044|
|Contact: Kai Wang, Dr. email@example.com|
|Principal Investigator: Kai Wang, Dr.|
|Principal Investigator:||Kai Wang, Dr.||Peking University People's Hospital|