NCT00919334

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

3.5 years

First QC Date

June 11, 2009

Last Update Submit

July 2, 2014

Conditions

Myopia

Keywords

Myopia progressionMyopia controlSimultaneous visionMyopic defocus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The changes of axial length

    every 6 months for 2 years

Study Arms (2)

single vision soft contact lens

NO INTERVENTION

Single vision soft contact lenses with same materials of the DISC lens

Defocus Incorporated Soft Contact (DISC) lens

EXPERIMENTAL

The use of DISC lens to slow down the progression of myopia

Device: Defocus Incorporated Soft Contact (DISC) lens

Interventions

Defocus Incorporated Soft Contact (DISC) lensDEVICE

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

Also known as: myopia control, myopia progression, Simultaneous vision, bifocal contact lens
Defocus Incorporated Soft Contact (DISC) lens

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optometry Clinic, School of Optometry, The Hong Kong PolyU

Hong Kong, China

Location

Related Publications (2)

  • 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: 24169657RESULT

  • Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

    PMID: 36809645DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Lenses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and Supplies

Study Officials

  • Carly SY Lam, PhD

    School of Optometry, The Hong Kong PolyU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of School

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

July 1, 2007

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

CN(1)