Myopia Control With Simultaneous Vision Approach

Myopia Clinical Trial

Official title:

Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919334
• Other study ID #: GRF5438/06M
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2009
• Last updated: July 2, 2014
• Start date: July 2007
• Est. completion date: June 2011

Study information

• Verified date: July 2014
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Defocus Incorporated Soft Contact (DISC) lens
Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia

Locations

Country	Name	City	State
China	Optometry Clinic, School of Optometry, The Hong Kong PolyU	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

References & Publications (1)

Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 6 months for 2 years	No
Secondary	The changes of axial length	Axial length was measured after cycloplegia using IOL Master	every 6 months for 2 years	No