Role of 0.01% Atropine in Myopia Control of High Myopic Children Of Moradabad (India)
- Conditions
- Other visual disturbances,
- Registration Number
- CTRI/2021/10/037447
- Lead Sponsor
- CL Gupta Eye Institute
- Brief Summary
Since last decades, the prevalence of myopia is increasing globally.1 It was estimated that by 2050, 49.8% of the world population will be myopic, and almost 1 billion people will have high myopia (9.8% of the world population).2High myopia is defined as “a condition in which the spherical equivalent objective refractive error is ≤ –5.00 D in either eyeâ€.3 It is also found to be associated with myopic macular degeneration, cataract, glaucoma, and serious, sight-threatening retinal damage.1,4 Due to these increased risk of complication it has a huge economic impact and is a public health concern in India5 as well as globally.1 Looking at its adverse social and economic impact, strategies to mitigate myopia progression are warranted in myopic as well as in high myopia patients. Strategies like; Orthokeratology, peripheral defocus contact lenses, bifocal or progressive addition spectacles, and increased involvement in outdoor activities have been found effective for controlling myopia progression in children.3,6
To date, atropine is the only drug that has demonstrated to have a dose dependent inhibitor effect on myopia progression.7,8 Chua et al reported that, high dose atropine (1%) had slowed down myopia progression by more than 75% over two years.9 Low dose atropine (0.05%, 0.01%) have also been shown to be effective in retardation of myopia progression.1,10,11 The most common side effect of atropine use is photophobia. Less frequent side effects are: dry mouth, face flush, headache, increased blood pressure, constipation, difficulty in micturition, and central nervous system disturbances. Previous studies have reported that over 5 years, low dose (0.01%) has less side effects than high dose (0.5% & 1%) concentration of atropine.1,11 Several studies on efficacy of atropine have been conducted on myopia children.9,10,11 However, there has been paucity of evidence available on the efficacy of low dose (0.01%) atropine in retardation of progression in high myopes. Its mechanism of action in retardation of myopia progression among high myopes is still debatable.
In this study, we hypothesized that atropine (0.01%) has a similar mechanism of action, safety and efficacy in high myopes. The objective of this study is to assess the safety and efficacy of low dose (0.01%) atropine eye drop in preventing myopia progression among children with high myopia.
**References:**
1. Wu, PC., Chuang, MN., Choi, J. et al. Update in myopia and treatment strategy of atropine use in myopia control. Eye 33, 3–13 (2019). <https://doi.org/10.1038/s41433-018-0139-7>
2. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. PMID: 26875007.
3. The impact of myopia and high myopia. Available from: https://www.who.int/blindness/causes/MyopiaReportforWeb.pdf. Accessed on: September 21, 2021
4. Ikuno Y. Overview of the complications of high myopia. Retina. 2017 Dec; 37(12):2347-2351. doi: 10.1097/IAE.0000000000001489. PMID: 28590964.
5. Saxena R, Vashist P, Menon V. Is myopia a public health problem in India? Indian J Community Med. 2013; 38(2):83-85. doi:10.4103/0970-0218.112436
6. Mak CY, Yam JC, Chen LJ, Lee SM, Young AL. Epidemiology of myopia and prevention of myopia progression in children in East Asia: a review. Hong Kong Med J. 2018 Dec;24(6):602-609. doi: 10.12809/hkmj187513. Epub 2018 Dec 3. PMID: 30530867.
7. Walline JJ, Lindsley K, Vedula SS, et al. Interventions to slow progression of myopia in children. Cochrane Database Syst Rev 2011:CD004916.
8. Huang J, Wen D, Wang Q, et al. Efficacy comparison of 16 interventions for myopia control in children: a network meta-analysis. Ophthalmology. 2016;123:697–708.
9. Chua, Wei-Han, Vivian Balakrishnan, Yiong-Huak Chan, Louis Tong, Yvonne Ling, Boon-Long Quah, and Donald Tan. "Atropine for the treatment of childhood myopia." Ophthalmology 113, no. 12 (2006): 2285-2291.
10. Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019 Jan;126(1):113-124. doi: 10.1016/j.ophtha.2018.05.029. Epub 2018 Jul 6. PMID: 30514630.
11. Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11. PMID: 26271839.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 78
Age: 6 to 16 years Myopia ≥ 5.00 D (cycloplegic refraction; spherical equivalent) No prior or current treatment for preventing myopia progression.
Best corrected visual acuity < 0.5 (6/12) Refractive Myopia Astigmatism ≥ 1.5 D Amblyopia Ocular hypertension / Glaucoma Prior intraocular surgery Allergy to atropine eye drops Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome History of cardiac or significant respiratory diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression of Myopia in Diopters (Spherical equivalent relative to baseline) 6 Month, 12 Month, 18 Month, 24 Month, 30 Month and 36 Month
- Secondary Outcome Measures
Name Time Method Change in axial length At 1 and 2 years
Trial Locations
- Locations (1)
Department of Pediatric ophthalmology, Strabismus and Neuro-Ophthalmology,
🇮🇳Moradabad, UTTAR PRADESH, India
Department of Pediatric ophthalmology, Strabismus and Neuro-Ophthalmology,🇮🇳Moradabad, UTTAR PRADESH, IndiaPradeep AgarwalPrincipal investigator9411072329drpradeep@clgei.org