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CTRI Number  CTRI/2021/10/037447 [Registered on: 21/10/2021] Trial Registered Prospectively
Last Modified On: 20/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of 0.01% Atropine in Myopia Control of High Myopic Children Of Moradabad (India)  
Scientific Title of Study   Efficacy of Low Dose Atropine in Prevention of Myopia Progression in Children with High Myopia 
Trial Acronym  CHAMP Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeep Agarwal 
Designation  Head-Department of Pediatric ophthalmology, Strabismus and Neuro-Ophthalmology 
Affiliation  CL Gupta Eye Institute 
Address  CL Gupta Eye Institute Ram Ganga Vihar Phase II Ext
Ram Ganga Vihar Phase II Ext
Moradabad
UTTAR PRADESH
244001
India 
Phone    
Fax    
Email  drpradeep@clgei.org  
 
Details of Contact Person
Scientific Query  
Name  Pradeep Agarwal 
Designation  Head-Department of Pediatric ophthalmology, Strabismus and Neuro-Ophthalmology 
Affiliation  CL Gupta Eye Institute 
Address  CL Gupta Eye Institute Ram Ganga Vihar Phase II Ext
Ram Ganga Vihar Phase II Ext
Moradabad
UTTAR PRADESH
244001
India 
Phone    
Fax    
Email  drpradeep@clgei.org  
 
Details of Contact Person
Public Query  
Name  Pradeep Agarwal 
Designation  Head-Department of Pediatric ophthalmology, Strabismus and Neuro-Ophthalmology 
Affiliation  CL Gupta Eye Institute 
Address  CL Gupta Eye Institute Ram Ganga Vihar Phase II Ext
Ram Ganga Vihar Phase II Ext
Moradabad
UTTAR PRADESH
244001
India 
Phone    
Fax    
Email  drpradeep@clgei.org  
 
Source of Monetary or Material Support  
CL Gupta Eye Institute 
 
Primary Sponsor  
Name  CL Gupta Eye Institute 
Address  Ram Ganga Vihar Phase II Ext Moradabad-244001, India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pradeep Agarwal  Department of Pediatric ophthalmology, Strabismus and Neuro-Ophthalmology,   Ground Floor, CL Gupta Eye Institute, Ram Ganga Vihar, Phase II (Ext) Moradabad-244001 India.
Moradabad
UTTAR PRADESH 		 9411072329

drpradeep@clgei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CL Gupta Eye Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H538||Other visual disturbances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atropine (0.01%)  One drop of topical 0.01% atropine daily at bed time for two years 
Comparator Agent  No Drug or placebo  No drug or placebo 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Age: 6 to 16 years
Myopia ≥ 5.00 D (cycloplegic refraction; spherical equivalent)
No prior or current treatment for preventing myopia progression 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Change in axial length  At 1 and 2 years  
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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).2  High myopia is defined as “a condition in which the spherical equivalent objective refractive error is ≤ –5.00 D in either eye”.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.

 

 
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