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OpenTrials
Completed

NCT Number: NCT00919334

Myopia Control With Simultaneous Vision Approach

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

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Optometry Clinic, School of Optometry, The Hong Kong PolyU

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Defocus Incorporated Soft Contact (DISC) lens

Device

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

Other names: myopia control, myopia progression, Simultaneous vision, bifocal contact lens

Primary outcomes

  1. The changes of cycloplegic refractive errors

    Time frame: 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 outcomes

  1. The changes of axial length

    Time frame: every 6 months for 2 years

    Axial length was measured after cycloplegia using IOL Master

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 12, 2009
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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