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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

Primary Purpose

Myopia

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Atropine Eye drops
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia treatment, Atropine

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written Informed Consent from parent and assent from child has been obtained Children aged 6 to 12 years Refractive error of spherical equivalent -2.00 D or worse 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 cycloplegic or non-cycloplegic autorefraction Distance vision correctable to logMAR 0.2 or better in both eyes A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D Normal intraocular pressure of not greater than 21 mmHg Normal ocular health other than myopia In good general health with no history of cardiac or significant respiratory diseases No asthma-requiring medications in the past one year No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride Willing and able to comply with scheduled visits and other study procedures Exclusion Criteria: Ocular or systemic diseases which may affect vision or refractive error Any ocular condition wherein topical atropine is contraindicated 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

Sites / Locations

  • Singapore Eye Research Institute

Outcomes

Primary Outcome Measures

Spherical equivalent refraction determined by cycloplegic autorefraction

Secondary Outcome Measures

Axial length determined by non-contact partial coherence interferometry
Ocular symptoms
Induced cycloplegia assessed by near acuity and amplitude of accommodation tests
Pupil reactivity and diameter assessment
Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry
Posterior segment changes assessed by fundus photography and ophthalmoscopy
Retinal function assessed by distance acuity test and electroretinography

Full Information

First Posted
August 30, 2006
Last Updated
August 30, 2010
Sponsor
Singapore National Eye Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00371124
Brief Title
Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
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 Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Singapore National Eye Centre

4. Oversight

5. Study Description

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.
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. Phase I: 2 years with 8 scheduled visits 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia treatment, Atropine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atropine Eye drops
Primary Outcome Measure Information:
Title
Spherical equivalent refraction determined by cycloplegic autorefraction
Secondary Outcome Measure Information:
Title
Axial length determined by non-contact partial coherence interferometry
Title
Ocular symptoms
Title
Induced cycloplegia assessed by near acuity and amplitude of accommodation tests
Title
Pupil reactivity and diameter assessment
Title
Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry
Title
Posterior segment changes assessed by fundus photography and ophthalmoscopy
Title
Retinal function assessed by distance acuity test and electroretinography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written Informed Consent from parent and assent from child has been obtained Children aged 6 to 12 years Refractive error of spherical equivalent -2.00 D or worse 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 cycloplegic or non-cycloplegic autorefraction Distance vision correctable to logMAR 0.2 or better in both eyes A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D Normal intraocular pressure of not greater than 21 mmHg Normal ocular health other than myopia In good general health with no history of cardiac or significant respiratory diseases No asthma-requiring medications in the past one year No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride Willing and able to comply with scheduled visits and other study procedures Exclusion Criteria: Ocular or systemic diseases which may affect vision or refractive error Any ocular condition wherein topical atropine is contraindicated 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Tan, FRCS
Organizational Affiliation
SNEC, SERI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Han Chua, FRCS
Organizational Affiliation
SNEC, SERI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
Citation
Chua WH, Balakrishnan V, Tan D, Chan YH, ATOM Study Group. Efficacy results from the atropine in the treatment of myopia (ATOM) study. Invest Ophthalmol Vis Sci 2003;44:E-Abstract 3119.
Results Reference
background
Citation
Chua WH, Balakrishnan V, Chan YH, ATOM Study Group. Analysis of the safety data from the atropine in the treatment of myopia (ATOM) study. Invest Ophthalmol Vis Sci 2002;43:E-Abstract 3329.
Results Reference
background
PubMed Identifier
8425826
Citation
McBrien NA, Moghaddam HO, Reeder AP. Atropine reduces experimental myopia and eye enlargement via a nonaccommodative mechanism. Invest Ophthalmol Vis Sci. 1993 Jan;34(1):205-15.
Results Reference
background
PubMed Identifier
11401629
Citation
Shih YF, Hsiao CK, Chen CJ, Chang CW, Hung PT, Lin LL. An intervention trial on efficacy of atropine and multi-focal glasses in controlling myopic progression. Acta Ophthalmol Scand. 2001 Jun;79(3):233-6. doi: 10.1034/j.1600-0420.2001.790304.x.
Results Reference
background
PubMed Identifier
10048351
Citation
Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.
Results Reference
background
PubMed Identifier
545205
Citation
Bedrossian RH. The effect of atropine on myopia. Ophthalmology. 1979 May;86(5):713-9. doi: 10.1016/s0161-6420(79)35455-0.
Results Reference
background
PubMed Identifier
16503774
Citation
Lee JJ, Fang PC, Yang IH, Chen CH, Lin PW, Lin SA, Kuo HK, Wu PC. Prevention of myopia progression with 0.05% atropine solution. J Ocul Pharmacol Ther. 2006 Feb;22(1):41-6. doi: 10.1089/jop.2006.22.41.
Results Reference
background
PubMed Identifier
26313301
Citation
Kumaran A, Htoon HM, Tan D, Chia A. Analysis of Changes in Refraction and Biometry of Atropine- and Placebo-Treated Eyes. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5650-5. doi: 10.1167/iovs.14-14716.
Results Reference
derived
PubMed Identifier
24315293
Citation
Chia A, Chua WH, Wen L, Fong A, Goon YY, Tan D. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014 Feb;157(2):451-457.e1. doi: 10.1016/j.ajo.2013.09.020. Epub 2013 Dec 4.
Results Reference
derived
PubMed Identifier
23292524
Citation
Chia A, Li W, Tan D, Luu CD. Full-field electroretinogram findings in children in the atropine treatment for myopia (ATOM2) study. Doc Ophthalmol. 2013 Jun;126(3):177-86. doi: 10.1007/s10633-012-9372-8. Epub 2013 Jan 5.
Results Reference
derived
Links:
URL
http://www.seri.com.sg/
Description
Singapore Eye Research Institute Website

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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

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