Myopia Control With Simultaneous Vision Approach

The Hong Kong Polytechnic University

Status and phase

Completed

Phase 1

Conditions

Myopia

Treatments

Device: Defocus Incorporated Soft Contact (DISC) lens

Study type

Interventional

Funder types

Other

Identifiers

NCT00919334

GRF5438/06M

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 patients

Sex

All

Ages

8 to 13 years old

Volunteers

Accepts Healthy Volunteers

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