Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

Progressive Myopia Clinical Trial

— DLTCAM  

Official title:

Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02001415
• Other study ID #: Z131107002213127
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2013
• Last updated: October 19, 2015
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: Peking University People's Hospital
• Contact: Kai Wang, Dr.
• Phone: +86-13810097881
• Email: medisaker[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Progressive Myopia

Intervention

Other:
• Spectacles
Normal spectacle lenses were used to correct myopia as the control group.
• Myovision
Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.
• Orthokeratology
Orthokeratology lenses.

Locations

Country	Name	City	State
China	Ophthalmology Department of Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 months, 12 months	No
Secondary	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.	Baseline, 6 months, 12 months	No