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Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02001415
Acronym
DLTCAM
Enrollment
120
Registered
2013-12-04
Start date
2013-11-30
Completion date
2016-09-30
Last updated
2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive Myopia

Keywords

Progressive Myopia, Contact Lenses, Spectacles

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.

Interventions

OTHERSpectacles

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

OTHERMyovision

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

Orthokeratology lenses.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Ocular Axial LengthBaseline, 6 months, 12 monthsOcular 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

MeasureTime frameDescription
Change of Spherical Equivalent RefractionBaseline, 6 months, 12 monthsSpherical 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.

Countries

China

Contacts

Primary ContactKai Wang, Dr.
medisaker@gmail.com+86-13810097881
Backup ContactXi Rong Wu, Dr.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026