Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia (DLTCAM)

Peking University

Status: Unknown

Conditions: Progressive Myopia

Treatments: Other: Spectacles; Other: Myovision; Other: Orthokeratology

Study type: Interventional

Funder types: Other

Identifiers

NCT02001415

Z131107002213127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 3 patient groups

Spectacles

Active Comparator group

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...).

Treatment:

Other: Spectacles

Myovison

Active Comparator group

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.

Treatment:

Other: Myovision

Ortho-K

Active Comparator group

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.

Treatment:

Other: Orthokeratology