Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

Not Applicable

• Conditions: Progressive Myopia
• Interventions: Other: Spectacles; Other: Orthokeratology; Other: Myovision

• Registration Number: NCT02001415
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-23
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-25
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spectacles	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...).
Ortho-K	Orthokeratology	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.
Myovison	Myovision	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.

Primary Outcome Measures

Name	Time	Method
Change of Ocular Axial Length	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

Name	Time	Method
Change of Spherical Equivalent Refraction	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.

Trial Locations

Locations (1)

Ophthalmology Department of Peking University People's Hospital; 🇨🇳 Beijing, China