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Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371124
Recruitment Status : Unknown
Verified May 2010 by Singapore National Eye Centre.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2006
Last Update Posted : August 31, 2010
Information provided by:
Singapore National Eye Centre

Brief Summary:
The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.

Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine Eye drops Phase 2 Phase 3

Detailed Description:

A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children

Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits.

  1. Phase I: 2 years with 8 scheduled visits
  2. Phase II: 3 years with 7 scheduled visits

STUDY DESIGN This study consists of 2 phases, each with a different design. Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years, with myopia of -2.00 D or worse in each eye, and from whom assent and parental/guardian consent have been obtained, will be randomised to receive 0.5% atropine, 0.1% atropine or 0.01% atropine once nightly in both eyes. Participants will be assigned to treatment in the ratio of 2:2:1, respectively. Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months.

Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment. Those children who demonstrate myopia progression of -0.5 D or more, at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes. The appropriate dose will be determined by analysis of the data from Phase I of the study. Treatment will be for a further 2 years and all children, including those not receiving treatment, will be reviewed every 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Spherical equivalent refraction determined by cycloplegic autorefraction

Secondary Outcome Measures :
  1. Axial length determined by non-contact partial coherence interferometry
  2. Ocular symptoms
  3. Induced cycloplegia assessed by near acuity and amplitude of accommodation tests
  4. Pupil reactivity and diameter assessment
  5. Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry
  6. Posterior segment changes assessed by fundus photography and ophthalmoscopy
  7. Retinal function assessed by distance acuity test and electroretinography

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written Informed Consent from parent and assent from child has been obtained
  2. Children aged 6 to 12 years
  3. Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction
  4. 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
  5. Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction
  6. Distance vision correctable to logMAR 0.2 or better in both eyes
  7. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D
  8. Normal intraocular pressure of not greater than 21 mmHg
  9. Normal ocular health other than myopia
  10. In good general health with no history of cardiac or significant respiratory diseases
  11. No asthma-requiring medications in the past one year
  12. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
  13. Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

  1. Ocular or systemic diseases which may affect vision or refractive error
  2. Any ocular condition wherein topical atropine is contraindicated
  3. Defective binocular function or stereopsis
  4. Amblyopia or manifest strabismus including intermittent tropia
  5. Previous or current use of atropine or pirenzepine
  6. Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371124

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Singapore Eye Research Institute
Singapore, Singapore
Sponsors and Collaborators
Singapore National Eye Centre
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Principal Investigator: Donald Tan, FRCS SNEC, SERI
Principal Investigator: Wei Han Chua, FRCS SNEC, SERI
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00371124    
Other Study ID Numbers: R359/17/2004
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: May 2010
Keywords provided by Singapore National Eye Centre:
Myopia treatment
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action