Back to resultsEfficacy Study of Different Lens Treatments on Chinese Adolescent Myopia (DLTCAM)
Primary Purpose
Progressive Myopia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spectacles
Myovision
Orthokeratology
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Myopia focused on measuring Progressive Myopia, Contact Lenses, Spectacles
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
Sites / Locations
- Ophthalmology Department of Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Spectacles
Myovison
Ortho-K
Arm Description
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...).
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.
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.
Outcomes
Primary Outcome Measures
Change of Ocular Axial Length
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
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.
Full Information
NCT ID
NCT02001415
First Posted
November 23, 2013
Last Updated
April 21, 2016
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02001415
Brief Title
Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia
Acronym
DLTCAM
Official Title
Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Myopia
Keywords
Progressive Myopia, Contact Lenses, Spectacles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spectacles
Arm Type
Active Comparator
Arm Description
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...).
Arm Title
Myovison
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ortho-K
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spectacles
Intervention Description
Normal spectacle lenses were used to correct myopia as the control group.
Intervention Type
Other
Intervention Name(s)
Myovision
Intervention Description
Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.
Intervention Type
Other
Intervention Name(s)
Orthokeratology
Intervention Description
Orthokeratology lenses.
Primary Outcome Measure Information:
Title
Change of Ocular Axial Length
Description
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.
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change of Spherical Equivalent Refraction
Description
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.
Time Frame
Baseline, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wang, Dr.
Phone
+86-13810097881
Email
medisaker@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Rong Wu, Dr.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Wang, Dr.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Department of Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Wang, Dr.
Email
medisaker@gmail.com
First Name & Middle Initial & Last Name & Degree
Kai Wang, Dr.
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia
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