Evaluation of the Efficacy and Safety of Atropine Eye Drops 0.01% in Slowing Myopia Progression in Children and Adolescents with High and Low Myopia: A Quasi experimental study

Hannan Masud; Fizzah  Batool; Samra  Nasir; Sarah Hannan

doi:10.51253/pafmj.v75iSUPPL-5.12439

Authors

Hannan Masud Department of Ophthalmology, Combined Military Hospital Kharian/National University of Medical Sciences (NUMS) Pakistan
Fizzah Batool Department of Ophthalmology, Combined Military Hospital Kharian/National University of Medical Sciences (NUMS) Pakistan
Samra Nasir Department of Ophthalmology, Combined Military Hospital Kharian/National University of Medical Sciences (NUMS) Pakistan
Sarah Hannan Department of Ophthalmology, Combined Military Hospital Kharian/National University of Medical Sciences (NUMS) Pakistan

DOI:

https://doi.org/10.51253/pafmj.v75iSUPPL-5.12439

Keywords:

Atropine, Axial length, Myopia progression

Abstract

Objective: To evaluate the efficacy and safety of Atropine eye drops 0.01% in slowing myopia progression in children and adolescents with high and low myopia.

Study Design: Quasi experimental study.

Place and Duration of Study: Combined Military Hospital, Kharian Pakistan, from Sep 2021 to Jul 2024

Methodology: Seventy-two patients (144 eyes) aged 5-18 years (8.47±3.04 years) with myopia progression (≥0.25mm AL or ≥0.75D SE over 3 months). Participants were stratified by high myopia (HM, AL>26.5mm, SE> -6D) and low myopia (LM, AL<26.5mm, SE< -6D) and randomly assigned to Atropine 0.01% or Control Groups. Double-blinding ensured neither participants nor investigators were aware of Group assignment. Both Groups received treatment for 24 months, with quarterly follow-ups recording AL and SE. The Control Group received placebo eye drops, identical in appearance and administration to the Atropine eye drops. Primary outcome measures included changes in AL and SE from baseline to 24 months, while secondary outcome measures included adverse events and quality of life questionnaires.
Results: In this study, total 144 eyes of 72 patients were included, with 72 eyes in intervention Group (Atropine eye drops 0.01%) and 72 eyes in Control Group (placebo eye drops). Atropine 0.01% eye drops significantly reduced myopia progression in children, with the Atropine Group showing smaller increases in axial length (25.32±1.53 mm vs. 25.80±1.77 mm) and spherical equivalent ....

Conclusion: The 0.01% Atropine eye drops effectively slowed myopia progression in both HM and LM Groups, with similar efficacy across different severity ranges.

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References

1. Loughman J, Flitcroft D. The acceptability and visual impact of 0.01% Atropine in a Caucasian population. Br J Ophthalmol 2016; 100(11): 1525-29.

https://doi.org/10.1136/bjophthalmol-2015-307861

2. Morgan, I.G.; French, A.N.; Ashby, R.S.; Guo, X.; Ding, X.; He, M.; Rose, K.A. The epidemics of myopia: Aetiology and prevention. Prog. Retin. Eye Res 2018, 62(1): 134–149.

https://doi.org/10.1016/j.preteyeres.2017.09.004

3. Vitale S, Ellwein L, Cotch MF, Ferris FL 3rd, Sperduto R. Prevalence of refractive error in the United States, 1999-2004. Arch Ophthalmol. 2008; 126(8): 1111-1119.

https://doi.org/10.1001/archopht.126.8.1111

4. Lundberg K, Suhr TA, Sogaard HR, Vestergaard AH, Jacobsen N, Goldschmidt E. et al. J. Physical Activity and Myopia in Danish Children—The CHAMPS Eye Study. Acta Ophthalmol 2018, 96: 134–141.

https://doi.org/10.1111/aos.13513

5. Shah SP, Jadoon MZ, Dineen B, Bourne RR, Johnson GJ, Gilbert CE, Khan MD. Refractive errors in the adult Pakistani population: the national blindness and visual impairment survey. Ophthalmic Epidemiol 2008; 15(3): 183-190.

https://doi.org/10.1080/09286580802105822

6. Shah A, Ishfaq A, Malik AM, Fatima M. Frequency of high myopia among students of University of Lahore. Ophthalmol Pak 2024; 13(3): 58-62.

https://doi.org/10.62276/OphthalmolPak.13.03.134

7. Wong TY, Ferreira A, Hughes R. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence based systemic review. Am J Ophthalmol 2014; 15(1): 9-25.

https://doi.org/10.1016/j.ajo.2013.08.010

8. Yam JC, Zhang XJ, Zhang Y, Wang YM, Tang SM, Li FF, et al. Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report. Ophthalmology 2022, 129(3): 308–321.

https://doi.org/10.1016/j.ophtha.2021.10.002

9. Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eye drops. Ophthalmology 2016, 123(2): 391–399.

https://doi.org/10.1016/j.ophtha.2015.07.004

10. Ashraf A, Masud H, Basit I, Awan MM. Effect of Atropine eye drops 0.01% on myopia progression in high and low myopia in patients visiting Armed Forces Institute of Ophthalmology Rawalpindi. Pak Armed Forces Med J 2020; 70(3): 700-704

11. Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE et al. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control : A Randomized Clinical Trial. JAMA Ophthalmol 2023, 141(8): 756–765.

https://doi.org/10.1001/jamaophthalmol.2023.2855

12. Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol 2023, 141(10): 990. https://doi.org/10.1001/jamaophthalmol.2023.2097

13. Loughman J, Kobia-Acquah E, Lingham G, Butler J, Loskutova E, Mackey DA, et al. Myopia outcome study of Atropine in children: Two-year result of daily 0.01% Atropine in a European population. Acta Ophthalmol. 2024; 102(3): e245-e256.

https://doi.org/10.1111/aos.15761

14. Lee SS, Lingham G, Blaszkowska M, Sanfilippo PG, Koay A, Franchina M, et al. Low-concentration Atropine eyedrops for myopia Control in a multi-racial cohort of Australian children: A randomised clinical trial. Clin. Exp. Ophthalmol 2022, 50, 1001–1012.

https://doi.org/10.1111/ceo.14148

15. Lee SSY, Mackey DA, Lingham G, Crewe JM, Richards MD, Chen FK, et al. Western Australia Atropine for the Treatment of Myopia (WA-ATOM) Study: Rationale, Methodology and Participant Baseline Characteristics. Clin. Exp. Ophthalmol 2020, 48, 569–579. https://doi.org/10.1111/ceo.13736

16. Yam JC, Li FF, Zhang X, Tang SM, Yip BHK, Kam KW, et al. Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report. Ophthalmology 2020, 127: 910–919.

https://doi.org/10.1016/j.ophtha.2019.12.011

17. Moriche-Carretero M, Revilla-Amores R, Diaz-Valle D, Morales-Fernández L, Gomez-de-Liaño R. Myopia progression and axial elongation in Spanish children: Efficacy of Atropine 0.01% eye-drops. J. Français D’ophtalmologie 2021, 44: 1499–1504.

https://doi.org/10.1016/j.jfo.2021.07.005

18. Diaz-Llopis M, Pinazo-Durán MD. Super diluted Atropine at 0.01% reduces progression in children and adolescents. A 5 year study of safety and effectiveness. Arch. Soc. Esp. Oftalmol 2018, 93: 182–185.

https://doi.org/10.1016/j.oftal.2017.12.015

19. Pérez-Flores I, Macías-Murelaga B, Barrio-Barrio J. Multicenter Group of Atropine Treatment for Myopia Control (GTAM). A multicenter Spanish study of Atropine 0.01% in childhood myopia progression. Sci. Rep 2021, 11: 21748.

https://doi.org/10.1038/s41598-021-00923-1

20. Sacchi M, Serafino M, Villani E, Tagliabue E, Luccarelli S, Bonsignore F, et al. Efficacy of Atropine 0.01% for the treatment of childhood myopia in European patients. Acta Ophthalmol 2019, 97: e1136–e1140. https://doi.org/10.1111/aos.14166

21. Kaymak H, Graff B, Schaeffel F, Langenbucher A, Seitz B, Schwahn H. A retrospective analysis of the therapeutic effects of 0.01% Atropine on axial length growth in children in a real-life clinical setting. Graefes Arch. Clin. Exp. Ophthalmol. 2021; 259:3083–3092. doi: 10.1007/s00417-021-05254-5.

22. Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, et al. Low Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Control led Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control . Ophthalmology 2019, 126: 113–124.

https://doi.org/10.1016/j.ophtha.2018.05.029

23. Yam JC, Zhang XJ, Zhang Y, Yip BHK, Tang F, Wong ES, et al. Effect of Low-Concentration Atropine Eye drops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial. JAMA 2023, 329: 472–481.

https://doi.org/10.1001/jama.2022.24162

24. Saleem T, Bokhari SA. Atropine 0.01% Eye Drops for Myopia Control in a tertiary care center of Pakistan: An interventional case series. Pak J Ophthalmol 2024; 40(2): 192-196.

https://doi.org/10.36351/pjo.v40i2.1762

25. Pineles SL, Kraker RT, Vander Veen DK, Hutchinson AK, Galvin JA, Wilson LB, et al. Atropine for the prevention of myopia progression in children: a report by the american academy of ophthalmology. Ophthalmol 2017; 124(12): 1857-66.

https://doi.org/10.1016/j.ophtha.2017.05.032