Myopia Control With Simultaneous Vision Approach

Phase 1CompletedNCT00919334

The Hong Kong Polytechnic University100 enrolled

Overview

To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Myopia

Interventions

Defocus Incorporated Soft Contact (DISC) lensDEVICE

Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia

Eligibility

Sex: ALLMin age: 8 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 8-13 years * Myopia (SE) between -1D to -5D * Astigmatism less than or equal to -1D * Anisometropia: less than or equal to 1.25D * aided VA (monocular): 0.00 log MAR or better * willingness to wear contact lens constantly * availability for follow-up for at least 2.5 years * parents' understanding and acceptance * willing to provide refractive status of grandparents Exclusion Criteria: * Severe ocular or systemic allergies * Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial * Ocular or systemic condition that might affect refractive development * Strabismus at distance or near * Prior use of bifocal or progressive lenses * Prior use of rigid gas permeable lenses and Ortho-K lenses

Locations (1)

Optometry Clinic, School of Optometry, The Hong Kong PolyU

Hong Kong, China

Outcomes

Primary Outcomes

The changes of cycloplegic refractive errors

Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.

Time frame: every 6 months for 2 years

Secondary Outcomes

The changes of axial length

Axial length was measured after cycloplegia using IOL Master

Time frame: every 6 months for 2 years

Data from ClinicalTrials.gov

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