NCT02130167

Brief Summary

Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 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

August 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

April 28, 2014

Last Update Submit

January 29, 2018

Conditions

Myopia Progression

Keywords

Myopia progressionLow concentration atropine

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic spherical refraction change

    Cycloplegic spherical refraction change is the main indicator of the myopia progression.

    1 year

Secondary Outcomes (1)

  • Axial length change

    1 year

Other Outcomes (3)

  • pupil size

    6 months

  • accommodation

    6 months

  • Questionnaire

    baseline and 6 months

Study Arms (2)

0.01% Atropine

EXPERIMENTAL
Drug: Atropine

0.05% Atropine

ACTIVE COMPARATOR
Drug: Atropine

Interventions

AtropineDRUG

Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine

0.01% Atropine0.05% Atropine

Eligibility Criteria

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

You may qualify if:

  • Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

You may not qualify if:

  • strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Interventions

Atropine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pei-Chang Wu, MD,PhD

    Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 5, 2014

Study Start

August 1, 2012

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

TW(1)