Low-Concentration Atropine for Myopia Progression (LAMP) Study

Abstract

Low-concentration atropine is an emerging therapy for myopia progression, but its efficacy and optimal concentration remain uncertain. Our study aimed to evaluate the efficacy and safety of low-concentration atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period.Design: Randomized, placebo-controlled, double-masked trial.Participants: A total of 438 children aged 4 to 12 years with myopia of at least À1.0 diopter (D) and astigmatism of À2.5 D or less.Methods: Participants were randomly assigned in a 1:1:1:1 ratio to receive 0.05%, 0.025%, and 0.01% atropine eye drops, or placebo eye drop, respectively, once nightly to both eyes for 1 year. Cycloplegic refraction, axial length (AL), accommodation amplitude, pupil diameter, and best-corrected visual acuity were measured at baseline, 2 weeks, 4 months, 8 months, and 12 months. Visual Function Questionnaire was administered at the 1-year visit.Main Outcome Measures: Changes in spherical equivalent (SE) and AL were measured, and their differences among groups were compared using generalized estimating equation.Results: After 1 year, the mean SE change was À0.27AE0.61 D, À0.46AE0.45 D, À0.59AE0.61 D, and À0.81AE0.53 D in the 0.05%, 0.025%, and 0.01% atropine groups, and placebo groups, respectively (P < 0.001), with a respective mean increase in AL of 0.20AE0.25 mm, 0.29AE0.20 mm, 0.36AE0.29 mm, and 0.41AE0.22 mm (P < 0.001). The accommodation amplitude was reduced by 1.98AE2.82 D, 1.61AE2.61 D, 0.26AE3.04 D, and 0.32AE2.91 D, respectively (P < 0.001). The pupil sizes under photopic and mesopic conditions were increased respectively by 1.03AE1.02 mm and 0.58AE0.63 mm in the 0.05% atropine group, 0.76AE0.90 mm and 0.43AE0.61 mm in the 0.025% atropine group, 0.49AE0.80 mm and 0.23AE0.46 mm in the 0.01% atropine group, and 0.13AE1.07 mm and 0.02AE0.55 mm in the placebo group (P < 0.001). Visual acuity and vision-related quality of life were not affected in each group.Conclusions: The 0.05%, 0.025%, and 0.01% atropine eye drops reduced myopia progression along a concentration-dependent response. All concentrations were well tolerated without an adverse effect on vision-related quality of life. Of the 3 concentrations used, 0.05% atropine was most effective in controlling SE progression and AL elongation over a period of 1 year. Ophthalmology 2019;126:113-124 ª 2018 by the American Academy of Ophthalmology Supplemental material available at www.aaojournal.org. Myopia is the most common ocular disorder worldwide with increasing prevalence over the past decades, predominantly in East Asia. [1][2][3][4] Its prevalence in young adults has been reported to be 96.5% in Korean military conscripts 5 and 94.9% in university students in China. 6 It is predicted that approximately half of the world's population will be myopic by 2050, with as much as 10% being highly myopic. 7,8 Notably, high myopia is associated with excessive eyeball growth leading to sight-threatening complications, including presenile cataract, glaucoma, retinal detachment, choro...

Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial

“…The efficacy of myopia control is comparable to those of orthokeratology (60%), 10 21 prismatic bifocal spectacle lenses (about 50%) 34 and bifocal soft contact lenses (50%-60%) 10 23 35 and relatively less when compared with high and low-dose atropine (70+%). [11][12][13][14] The DIMS lenses have slowed myopia progression, and have stopped myopia progression in some children (online supplementary eFigures 2 and 3). 21.5% of children in the DIMS group had no myopia progression over 2 years whereas only 7.4% in the control group.…”

Higher order aberrations, refractive error development and myopia control: a review

“…Arguably the myopia intervention that has shown the greatest efficacy in animals and humans is the non‐selective anti‐muscarinic pharmacological agent, atropine. Atropine reduces myopia progression in a dose‐dependent manner, although, questions remain about its efficacy in slowing axial elongation, particularly for lower concentrations . Given the cycloplegic effect of atropine in humans, its mechanism of myopia control was originally thought to be related to changes in the accommodative system .…”

“…Atropine reduces myopia progression in a dose-dependent manner, [144][145][146] although, questions remain about its efficacy in slowing axial elongation, particularly for lower concentrations. 146,147 Given the cycloplegic effect of atropine in humans, 148 its mechanism of myopia control was originally thought to be related to changes in the accommodative system. 149 However, animal studies suggest that anti-muscarinic agents influence growth via an alternative, nonaccommodative mechanism.…”

<p>Pathogenesis and Prevention of Worsening Axial Elongation in Pathological Myopia</p>

“…A recent study conducted by Yam et al states that 0.05%, 0.025% and 0.01% atropine eye drops reduce myopia progression and exert a concentration-dependent reaction, of which 0.05% atropine was the most effective in controlling progression of spherical equivalent and axial elongation. 138 It is evident that atropine plays a significant role in controlling myopia progression either alone or in combination with another therapeutic regimen. Table 2 displays the role of atropine in the treatment of myopia progression over the years.…”