Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia (DLTCAM)
|ClinicalTrials.gov Identifier: NCT02001415|
Recruitment Status : Unknown
Verified April 2016 by Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted : December 4, 2013
Last Update Posted : April 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Progressive Myopia||Other: Spectacles Other: Myovision Other: Orthokeratology||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
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.
- 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.
- Change of Spherical Equivalent Refraction [ Time Frame: Baseline, 6 months, 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001415
|Contact: Kai Wang, Dr.||+email@example.com|
|Contact: Xi Rong Wu, Dr.|
|Ophthalmology Department of Peking University People's Hospital||Recruiting|
|Beijing, China, 100044|
|Contact: Kai Wang, Dr. firstname.lastname@example.org|
|Principal Investigator: Kai Wang, Dr.|
|Principal Investigator:||Kai Wang, Dr.||Peking University People's Hospital|