NCT00541177

Brief Summary

The purpose of this study is to test the hypothesis that myopia can be prevented by using a low concentration of atropine eyedrops once a week.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

October 6, 2007

Last Update Submit

October 9, 2007

Conditions

Myopia

Keywords

prevention myopia

Outcome Measures

Primary Outcomes (1)

  • cycloplegic refraction, visual acuity

    one year

Secondary Outcomes (1)

  • axial length

    one year

Study Arms (2)

1

EXPERIMENTAL

use 0.25% atropine once a week

Drug: atropine

2

ACTIVE COMPARATOR

use 0.5% tropicamide everyday

Drug: tropicamide

Interventions

atropineDRUG

0.25% atropine

1
tropicamideDRUG

0.5% tropicamide

2

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 7 to 12 years old
  • Has pre-myopia (spherical equivalent between +0.50 and -0.75) after cycloplegic refraction.
  • Visual acuity of naked eyes are above 0.6.
  • Astigmatism is less than -1.0D and anisometropia less than 1.0D.

You may not qualify if:

  • Has tropia, amblyopia, eyelid disease, or ocular problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Min-Sheng General Hospital

Taoyuan District, Tao-Yuan, Taiwan

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

AtropineTropicamide

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Leon Chih-Kai Liang, MD MMS

    Min-Sheng General Hospital; National Yang-Ming university, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leon Chih-Kai Liang, MD MMS

CONTACT

03-3179599eye.care@msa.hinet.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2007

First Posted

October 10, 2007

Study Start

April 1, 2007

Study Completion

March 1, 2008

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

TW(1)