NCT00371124

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Last Updated

August 31, 2010

Status Verified

May 1, 2010

First QC Date

August 30, 2006

Last Update Submit

August 30, 2010

Conditions

Myopia

Keywords

Myopia treatmentAtropine

Outcome Measures

Primary Outcomes (1)

  • Spherical equivalent refraction determined by cycloplegic autorefraction

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Atropine Eye dropsDRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore

Location

Related Publications (11)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 8425826BACKGROUND

  • 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.

    PMID: 11401629BACKGROUND

  • 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.

    PMID: 10048351BACKGROUND

  • Bedrossian RH. The effect of atropine on myopia. Ophthalmology. 1979 May;86(5):713-9. doi: 10.1016/s0161-6420(79)35455-0.

    PMID: 545205BACKGROUND

  • 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.

    PMID: 16503774BACKGROUND

  • 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.

    PMID: 36809645DERIVED

  • 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.

    PMID: 26313301DERIVED

  • 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.

    PMID: 24315293DERIVED

  • 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.

    PMID: 23292524DERIVED

Related Links

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Donald Tan, FRCS

    SNEC, SERI

    PRINCIPAL INVESTIGATOR

  • Wei Han Chua, FRCS

    SNEC, SERI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

March 1, 2006

Last Updated

August 31, 2010

Record last verified: 2010-05

Locations

SG(1)