Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

NCT ID: NCT02001415

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Progressive Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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...).

Group Type ACTIVE_COMPARATOR

Spectacles

Intervention Type OTHER

Normal spectacle lenses were used to correct myopia as the control group.

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.

Group Type ACTIVE_COMPARATOR

Myovision

Intervention Type OTHER

Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.

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.

Group Type ACTIVE_COMPARATOR

Orthokeratology

Intervention Type OTHER

Orthokeratology lenses.

Interventions

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Spectacles

Normal spectacle lenses were used to correct myopia as the control group.

Intervention Type OTHER

Myovision

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

Orthokeratology

Orthokeratology lenses.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kai Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Ophthalmology Department of Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Wang, Dr.

Role: CONTACT

+86-13810097881

Xi Rong Wu, Dr.

Role: CONTACT

Facility Contacts

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Kai Wang, Dr.

Role: primary

Other Identifiers

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Z131107002213127

Identifier Type: -

Identifier Source: org_study_id

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