Elsevier

Ophthalmology

Volume 123, Issue 2, February 2016, Pages 391-399
Ophthalmology

Original article
Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops

https://doi.org/10.1016/j.ophtha.2015.07.004Get rights and content

Purpose

To compare the safety and efficacy of different concentrations of atropine eyedrops in controlling myopia progression over 5 years.

Design

Randomized, double-masked clinical trial.

Participants

A total of 400 children originally randomized to receive atropine 0.5%, 0.1%, or 0.01% once daily in both eyes in a 2:2:1 ratio.

Methods

Children received atropine for 24 months (phase 1), after which medication was stopped for 12 months (phase 2). Children who had myopia progression (≥−0.50 diopters [D] in at least 1 eye) during phase 2 were restarted on atropine 0.01% for a further 24 months (phase 3).

Main Outcome Measures

Change in spherical equivalent and axial length over 5 years.

Results

There was a dose-related response in phase 1 with a greater effect in higher doses, but an inverse dose-related increase in myopia during phase 2 (washout), resulting in atropine 0.01% being most effective in reducing myopia progression at 3 years. Some 24%, 59%, and 68% of children originally in the atropine 0.01%, 0.1%, and 0.5% groups, respectively, who progressed in phase 2 were restarted on atropine 0.01%. Younger children and those with greater myopic progression in year 1 were more likely to require re-treatment. The lower myopia progression in the 0.01% group persisted during phase 3, with overall myopia progression and change in axial elongation at the end of 5 years being lowest in this group (−1.38±0.98 D; 0.75±0.48 mm) compared with the 0.1% (−1.83±1.16 D, P = 0.003; 0.85±0.53 mm, P = 0.144) and 0.5% (−1.98±1.10 D, P < 0.001; 0.87±0.49 mm, P = 0.075) groups. Atropine 0.01% also caused minimal pupil dilation (0.8 mm), minimal loss of accommodation (2–3 D), and no near visual loss compared with higher doses.

Conclusions

Over 5 years, atropine 0.01% eyedrops were more effective in slowing myopia progression with less visual side effects compared with higher doses of atropine.

Section snippets

Methods

In phase 1 of the ATOM2 study (treatment phase), 400 Asian children (aged 6–12 years) with myopia of −2.00 D or worse in each eye were randomized to receive atropine 0.01%, 0.1%, and 0.5% once nightly in both eyes for 2 years. Children were assigned to treatment in a 1:2:2 ratio, stratified by 6 gender and age strata. In phase 2 (washout phase), atropine was stopped and children were monitored for 12 months. In phase 3 (re-treatment phase), children who exhibited myopia progression of −0.50 D

Results

Among the 400 children enrolled in the study, 44 were lost in phase 1 and 11 were lost in phase 2, with 345 (86%) continuing to phase 3 (Fig 1). Children still in the study at the start of phase 3 were more myopic at baseline but had less myopic progression over the first year compared with children who were lost to follow-up (Table 1). The majority of the children (91%) were of ethnic Chinese origin.

Of the 345 children, 192 (56%) were restarted on atropine 0.01% because they had progressed 0.5

Discussion

In our first randomized placebo-controlled clinical trial using atropine eyedrops to control myopia progression in children (ATOM1), we established the clinical safety and efficacy of atropine 1% at least in the short term.16, 18 In phase 1 of ATOM2, we established that atropine 0.01% was almost as effective in reducing myopia progression as higher concentrations but with minimal pupil dilation accommodation and near vision loss.19, 20 In phase 2, we further established that children receiving

References (27)

  • P.E. Romano et al.

    Management of progressive school myopia with topical atropine eyedrops and photochromic bifocal spectacles

    Binocul Vis Strabismus Q

    (2000)
  • R.H. Kennedy et al.

    Reducing the progression of myopia with atropine: a long term cohort study of Olmsted County students

    Binocul Vis Strabismus Q

    (2000)
  • M.F. Chiang et al.

    Treatment of childhood myopia with atropine eyedrops and bifocal spectacles

    Binocul Vis Strabismus Q

    (2001)
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    Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

    Supported by grants from the National Medical Research Council (MH 95:03/1-23) and SingHealth (SHF/FG039/2004 and TEST 08-03).

    Author Contributions:

    Conception and design: Chia, Lu, Tan

    Data acquisition and/or research execution: Chia, Lu, Tan

    Analysis and interpretation: Chia, Lu, Tan

    Obtained funding: Tan

    Overall responsibility: Chia, Lu, Tan

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