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Five-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 4 Report
Xiu Juan Zhang1, Yuzhou Zhang2, Benjamin H K Yip3
1Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Shantou, China.
Insights
Continued low-concentration atropine effectively controls myopia over 5 years. Most children require re-treatment after cessation, with restarted 0.05% atropine showing similar efficacy to ongoing treatment.
Area of Science:
- Ophthalmology
- Pediatric Optometry
- Myopia Control Research
Background:
- The Low-Concentration Atropine for Myopia Progression (LAMP) study investigated atropine efficacy.
- This extended trial evaluates long-term outcomes and re-treatment strategies.
Purpose of the Study:
- To assess the 5-year efficacy of low-concentration atropine for myopia control.
- To determine the rate and factors influencing re-treatment needs.
- To evaluate the effectiveness of pro re nata (PRN) re-treatment with 0.05% atropine.
Main Methods:
- A 5-year randomized, double-masked extended trial involving children aged 4-12.
- Participants were randomized to continued treatment or cessation at year 3, with subsequent switch to 0.05% atropine or PRN re-treatment.
- Generalized estimating equations analyzed changes in spherical equivalent (SE) and axial length (AL).
Main Results:
- Over 5 years, cumulative mean SE progression was lowest with continued 0.05% atropine (-1.34 D).
- Axial length elongation also showed similar trends, favoring higher concentrations.
- 87.9% of children in the PRN group required re-treatment, with similar efficacy to continued treatment groups from years 3-5.
Conclusions:
- Continued 0.05% atropine demonstrates sustained efficacy in myopia control over 5 years.
- A significant proportion of children require re-treatment upon cessation, with restarted 0.05% atropine being effective.
- Consider re-treatment for myopia progression after treatment cessation.
Purpose:
To evaluate (1) the long-term efficacy of low-concentration atropine over 5 years, (2) the proportion of children requiring re-treatment and associated factors, and (3) the efficacy of pro re nata (PRN) re-treatment using 0.05% atropine from years 3 to 5.
Design:
Randomized, double-masked extended trial.
Participants:
Children 4 to 12 years of age originally from the Low-Concentration Atropine for Myopia Progression (LAMP) study.
Methods:
Children 4 to 12 years of age originally from the LAMP study were followed up for 5 years. During the third year, children in each group originally receiving 0.05%, 0.025%, and 0.01% atropine were randomized to continued treatment and treatment cessation. During years 4 and 5, all continued treatment subgroups were switched to 0.05% atropine for continued treatment, whereas all treatment cessation subgroups followed a PRN re-treatment protocol to resume 0.05% atropine for children with myopic progressions of 0.5 diopter (D) or more over 1 year. Generalized estimating equations were used to compare the changes in spherical equivalent (SE) progression and axial length (AL) elongation among groups.
Main Outcomes Measures:
(1) Changes in SE and AL in different groups over 5 years, (2) the proportion of children who needed re-treatment, and (3) changes in SE and AL in the continued treatment and PRN re-treatment groups from years 3 to 5.
Results:
Two hundred seventy (82.8%) of 326 children (82.5%) from the third year completed 5 years of follow-up. Over 5 years, the cumulative mean SE progressions were -1.34 ± 1.40 D, -1.97 ± 1.03 D, and -2.34 ± 1.71 D for the continued treatment groups with initial 0.05%, 0.025%, and 0.01% atropine, respectively (P = 0.02). Similar trends were observed in AL elongation (P = 0.01). Among the PRN re-treatment group, 87.9% of children (94/107) needed re-treatment. The proportion of re-treatment across all studied concentrations was similar (P = 0.76). The SE progressions for continued treatment and PRN re-treatment groups from years 3 to 5 were -0.97 ± 0.82 D and -1.00 ± 0.74 D (P = 0.55) and the AL elongations were 0.51 ± 0.34 mm and 0.49 ± 0.32 mm (P = 0.84), respectively.
Conclusions:
Over 5 years, the continued 0.05% atropine treatment demonstrated good efficacy for myopia control. Most children needed to restart treatment after atropine cessation at year 3. Restarted treatment with 0.05% atropine achieved similar efficacy as continued treatment. Children should be considered for re-treatment if myopia progresses after treatment cessation.
Financial Disclosure(S):
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
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