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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT02001415
First received: November 23, 2013
Last updated: June 4, 2014
Last verified: June 2014
  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
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

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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02001415     History of Changes
Other Study ID Numbers: Z131107002213127
Study First Received: November 23, 2013
Last Updated: June 4, 2014
Health Authority: China: Ministry of Health
China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014