drugset / Trial / NCT00371124
Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-03
- Primary completion
- —
- Completion
- —
Publications
- Background 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.
- Background 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.
- Background 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.
- Background Bedrossian RH. The effect of atropine on myopia. Ophthalmology. 1979 May;86(5):713-9. doi: 10.1016/s0161-6420(79)35455-0.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atropine | Other / unclassified | 0.01 % | Other |
| Subject | Atropine | Other / unclassified | 0.1 % | Other |
| Subject | Atropine | Other / unclassified | 0.5 % | Other |