Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

NCT02001415 | Unknown DMC

• 1 other identifier: Z131107002213127
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Myopia

Keywords

Progressive Myopia; Contact Lenses; Spectacles

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change of Spherical Equivalent Refraction

  Baseline, 6 months, 12 months

Study Arms (3)

Spectacles

ACTIVE COMPARATOR

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...).

Other: Spectacles

Myovison

ACTIVE COMPARATOR

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.

Other: Myovision

Ortho-K

ACTIVE COMPARATOR

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.

Other: Orthokeratology

Interventions

Spectacles OTHER

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

Spectacles

Myovision OTHER

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

Myovison

Orthokeratology OTHER

Orthokeratology lenses.

Ortho-K

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Existence of any ocular diseases except ametropia
• Hyperopia
• Severe dry eye

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Ophthalmology Department of Peking University People's Hospital

Beijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Myopia, Degenerative

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Kai Wang, Dr.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Wang, Dr.

CONTACT

+86-13810097881; medisaker@gmail.com

Xi Rong Wu, Dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2013
• First Posted: December 4, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

CN (1)