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

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• 作者：Audrey Chia ; FRANZCO ; PhD¹ ; ² ; Qing-Shu Lu ; PhD³ ; ⁴ ; Donald Tan ; FRCS ; FRCOphth¹ ; ² ; ⁴ ; ⁵ ; ^{donald.tan.t.h@snec.com.sg" class="auth_mail" title="E-mail the corresponding author}
• 关键词：AL ; axial length ; ATOM ; Atropine for Treatment of Myopia ; D ; diopters
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：123
• 期：2
• 页码：391-399
• 全文大小：1391 K

文摘

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.