Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
NCT ID: NCT00371124
Last Updated: 2010-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
400 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Atropine Eye drops
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
12 Years
ALL
No
Sponsors
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Singapore National Eye Centre
OTHER_GOV
Principal Investigators
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Donald Tan, FRCS
Role: PRINCIPAL_INVESTIGATOR
SNEC, SERI
Wei Han Chua, FRCS
Role: PRINCIPAL_INVESTIGATOR
SNEC, SERI
Locations
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Singapore Eye Research Institute
Singapore, , Singapore
Countries
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References
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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.
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.
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.
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.
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.
Bedrossian RH. The effect of atropine on myopia. Ophthalmology. 1979 May;86(5):713-9. doi: 10.1016/s0161-6420(79)35455-0.
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.
Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
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.
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.
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.
Related Links
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Singapore Eye Research Institute Website
Singapore National Eye Centre Website
Other Identifiers
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R359/17/2004
Identifier Type: -
Identifier Source: org_study_id