NCT00400140

Brief Summary

The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 12, 2010

Status Verified

May 1, 2010

Enrollment Period

1.9 years

First QC Date

November 15, 2006

Last Update Submit

May 11, 2010

Conditions

Myopia

Keywords

Myopia, defocus

Outcome Measures

Primary Outcomes (1)

  • Myopia progression as measured by spherical equivalent, and axial length

    12 month

Study Arms (1)

A

EXPERIMENTAL
Device: Hyperopic lens

Interventions

Hyperopic lensDEVICE

+3 D glasses

A

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 to 12 years
  • Refractive error of spherical equivalent -1.00 D to -6.00D in each eye as measured by cycloplegic autorefraction
  • Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
  • Astigmatism of less than or equal to -1.50 D as measured by non-cycloplegic or cycloplegic autorefraction
  • Distance vision correctable to logMAR 0.1 or better in both eyes
  • Normal intraocular pressure of not greater than 21 mmHg
  • Normal ocular health other than myopia
  • In good general health
  • Willing and able to comply with scheduled visits and other study procedures

You may not qualify if:

  • Baseline Anisometropia of \> 1.5D
  • Ocular or systemic diseases which may affect vision or refractive error
  • Defective binocular function or stereopsis
  • Amblyopia or manifest strabismus including intermittent tropia
  • Previous or current use of atropine or pirenzepine
  • Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
  • Allergy to cyclopentolate, proparacaine and benzalkonium chloride

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNEC

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Audrey Chia, FRANZCO

    Singapore National Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

November 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 12, 2010

Record last verified: 2010-05

Locations

SG(1)