Myopia Control With Simultaneous Vision Approach

Phase 1

Completed

• Conditions: Myopia
• Interventions: Device: Defocus Incorporated Soft Contact (DISC) lens

• Registration Number: NCT00919334
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2011-01
• Study Completion: 2011-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Defocus Incorporated Soft Contact (DISC) lens	Defocus Incorporated Soft Contact (DISC) lens	The use of DISC lens to slow down the progression of myopia

Primary Outcome Measures

Name	Time	Method
The changes of cycloplegic refractive errors	every 6 months for 2 years	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.

Secondary Outcome Measures

Name	Time	Method
The changes of axial length	every 6 months for 2 years	Axial length was measured after cycloplegia using IOL Master

Trial Locations

Locations (1)

Optometry Clinic, School of Optometry, The Hong Kong PolyU; 🇨🇳 Hong Kong, China