Myopia Control Using Soft Bifocal Lenses

NCT02643758 | Terminated

• 1 other identifier: HSEARS20151016008
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. Visual manipulations induced by multifocal soft CLs with high addition have been shown to inhibit eye growth and myopia development in children by recent studies. Several theories have been proposed including alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations. However, those theories remain to be proven and the optical properties and performance of multifocal soft CLs have not been investigated in children.

Conditions

Myopia

Keywords

Myopia control, bifocal soft contact lenses, children

Outcome Measures

Primary Outcomes (2)

• Changes in axial length in 2 years

  Evaluate the changes in cycloplegic axial length in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation

  Every 6 months for a period of 2 years

• Changes in cycloplegic refractive error in 2 years

  Evaluate the changes in cycloplegic refractive error in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation

  Every 6 months for a period of 2 years

Secondary Outcomes (3)

• Changes in wavefront aberrations in 2 years

  Every 6 months for a period of 2 years

• Changes in accommodation responses in 2 years

  Every 6 months for a period of 2 years

• Changes in wavefront aberrations of children with bifocal soft contact lenses in 2 years

  Every 6 months for a period of 2 years

Study Arms (2)

Bifocal soft contact lenses

EXPERIMENTAL

Device: Bifocal soft contact lenses Use of bifocal contact lenses with nasally decentered optical zone to control the progression of myopia

Device: Bifocal soft contact lenses

Single vision spectacles

NO INTERVENTION

Control: Single vision spectacles

Interventions

Bifocal soft contact lenses DEVICE

Also known as: Menicon Duo 2 week soft bifocal lenses

Bifocal soft contact lenses

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Refractive sphere: -0.75 D to -4.50 D
• Refractive cylinder: not exceed 1.00 D
• Spherical equivalent: -0.75 D to -5.00 D
• Best corrected distance VA (LogMAR): 0.14 or better in each eye and 0.10 or better in both eyes
• Difference in refractive error (spherical equivalent) in the two eyes: not exceed 1.00 D

You may not qualify if:

• Prior history of myopia control treatment
• Contraindication to contact lens wear
• Binocular anomalies (e.g. strabismus)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Menicon Co., Ltd.: collaborator
• Queensland University of Technology: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Related Publications (7)

• Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.

  PMID: 21276616 BACKGROUND

• Fujikado T, Ninomiya S, Kobayashi T, Suzaki A, Nakada M, Nishida K. Effect of low-addition soft contact lenses with decentered optical design on myopia progression in children: a pilot study. Clin Ophthalmol. 2014 Sep 23;8:1947-56. doi: 10.2147/OPTH.S66884. eCollection 2014.

  PMID: 25284981 BACKGROUND

• 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-2013-303914. Epub 2013 Oct 29.

  PMID: 24169657 BACKGROUND

• Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.

  PMID: 22039230 BACKGROUND

• Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia control. Optom Vis Sci. 2013 Nov;90(11):1207-14. doi: 10.1097/OPX.0000000000000036.

  PMID: 24061152 BACKGROUND

• Gifford P, Cannon T, Lee C, Lee D, Lee HF, Swarbrick HA. Ocular aberrations and visual function with multifocal versus single vision soft contact lenses. Cont Lens Anterior Eye. 2013 Apr;36(2):66-73; quiz 103-4. doi: 10.1016/j.clae.2012.10.078. Epub 2012 Nov 10.

  PMID: 23146418 BACKGROUND

• Llorente-Guillemot A, Garcia-Lazaro S, Ferrer-Blasco T, Perez-Cambrodi RJ, Cervino A. Visual performance with simultaneous vision multifocal contact lenses. Clin Exp Optom. 2012 Jan;95(1):54-9. doi: 10.1111/j.1444-0938.2011.00666.x. Epub 2011 Nov 10.

  PMID: 22070196 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pauline Cho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 31, 2015
• Study Start: January 25, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

HK (1)