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Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia (DLTCAM)

This study is currently recruiting participants.
Verified April 2016 by Peking University People's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02001415
First Posted: December 4, 2013
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Peking University People's Hospital
  Purpose
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.

Condition Intervention
Progressive Myopia Other: Spectacles Other: Myovision Other: Orthokeratology

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 120
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)
Arms Assigned Interventions
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...).
Other: Spectacles
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.
Other: Myovision
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.
Other: Orthokeratology
Orthokeratology lenses.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001415


Contacts
Contact: Kai Wang, Dr. +86-13810097881 medisaker@gmail.com
Contact: Xi Rong Wu, Dr.

Locations
China
Ophthalmology Department of Peking University People's Hospital Recruiting
Beijing, China, 100044
Contact: Kai Wang, Dr.       medisaker@gmail.com   
Principal Investigator: Kai Wang, Dr.         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Kai Wang, Dr. Peking University People's Hospital
  More Information

Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02001415     History of Changes
Other Study ID Numbers: Z131107002213127
First Submitted: November 23, 2013
First Posted: December 4, 2013
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Peking University People's Hospital:
Progressive Myopia
Contact Lenses
Spectacles

Additional relevant MeSH terms:
Myopia
Myopia, Degenerative
Refractive Errors
Eye Diseases