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CTRI Number  CTRI/2024/03/063869 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Finding the best way to stop atropine eye drops to minimize rebound myopia: A study on slow, very slow, and sudden cessation of atropine eye drops with lifestyle changes. 
Scientific Title of Study   A Randomized Controlled Trial of Gradual (Slow Versus Very Slow) Versus Sudden Cessation of Atropine Therapy and Monitored Lifestyle Changes in the Incidence and Magnitude of Rebound Myopia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Jain 
Designation  PG 1st year (DNB) Student 
Affiliation  Jupiter Hospital 
Address  Jupiter Lifeline Hospitals, Service Road, Eastern Express Highway, next to Viviana Mall, Thane.

Mumbai
MAHARASHTRA
4000601
India 
Phone  9769057479  
Fax    
Email  snehajain798@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mihir Kothari 
Designation  Consultant  
Affiliation  Jupiter Hospital 
Address  Jupiter Netralay, 6th floor, Jupiter Lifeline Hospitals, room no. 1, Service Road, Eastern Express Highway, next to Viviana Mall, Thane.

Mumbai
MAHARASHTRA
400601
India 
Phone  93204037173  
Fax    
Email  drmihirkothari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vishram Sangit 
Designation  Senior consultant (Head of department of ophthalmology) 
Affiliation  Jupiter Hospital 
Address  Jupiter Lifeline Hospitals, Service Road, Eastern Express Highway, next to Viviana Mall, Thane.

Mumbai
MAHARASHTRA
400601
India 
Phone  9594045556  
Fax    
Email  drvishram.sangit@gmail.com  
 
Source of Monetary or Material Support  
Jupiter Hospital 
 
Primary Sponsor  
Name  Sneha Jain 
Address  Jupiter Hospital, Service Road, Eastern Express Highway, next to Viviana Mall, Thane, 400601 
Type of Sponsor  Other [self] 
 
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 
Dr Sneha Jain  Jupiter Hospital  Service Road, Eastern Express Highway, next to Viviana Mall, Thane West - 400601.
Mumbai
MAHARASHTRA 
9769057479

snehajain798@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Prompt cessation of atropine eye drop in low myopic eye.   In both groups, A and B, the low myopic or nondominant eye will undergo prompt cessation of atropine eye drops. 
Intervention  Tapering of atropine eye drop in high myopic eye.  For Group A, in high myopic or dominant eye, atropine eye drop will be tapered over 7 months (one day per week per month). For Group B, in high myopic or dominant eye, atropine eye drop will be tapered over 3 months.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Magnitude of myopia at least -1D in each eye.
Astigmatism less than 4.5D in each eye.
Documented nonprogressive myopia i.e. 0D and axial length progression less than 0.2mm per year.
Children who are on atropine eye drop therapy at any frequency and various concentration
 
 
ExclusionCriteria 
Details  Allergic to atropine.
Any comorbidities systemic as well as ocular
Children who have pathological myopia
BCVA less than 20 by 40 and 6 by 24
Axial length more than 26.5mm
OCT macula abnormal 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Myopia in diopter (sphere)  13 months 
 
Secondary Outcome  
Outcome  TimePoints 
Axial length in mm  13 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   16/03/2024 
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="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Atropine eye drop therapy has emerged as a globally accepted and effective intervention for slowing down myopia progression. Numerous studies highlight the efficacy of atropine therapy in mitigating myopia progression, often complemented by increased outdoor daylight activities and reduced screen time. However, the recent ATOM2 study(phase 2- washout period) revealed a concerning phenomenon known as rebound myopia, characterized by a worsening of myopia (progression of >0.5D) after the cessation of atropine therapy.
Remarkably, despite the growing significance of atropine therapy in myopia management, there is a notable lack of published guidance on strategically ceasing atropine treatment to minimize the incidence and magnitude of rebound myopia. Additionally, the role of monitored lifestyle changes, such as outdoor activities and screen time reduction, in addressing rebound myopia remains largely unexplored.
This study aims to fill this critical gap by assessing the efficacy of two atropine cessation regimes- gradual (slow vs very slow) versus sudden cessation of atropine therapy. Simultaneously, the research seeks to delineate the impact of monitored lifestyle changes on the incidence and magnitude of rebound myopia.
Methods;
The study will involve the randomization of patients into two groups, namely Group A and Group B. the group of children, the higher myopic eye will undergo a gradual tapering of atropine eye drops over 7 months, while the low myopic eye will undergo sudden cessation of atropine therapy. Lifestyle modification advice will be provided in this group. in group B children, the high myopic eye will undergo gradual tapering of atropine eye drop therapy over 3 months and the lower myopic eye will undergo sudden cessation of atropine eye drop. lifestyle modification including over 45 minutes of daily outdoor daylight activity and less than 1 hour of screen time, will be monitored using monitoring charts.
Patients will be followed up every three months, during which refractive power and axial length will be measured. The recruitment period for this comprehensive study is expected to span 13 months, aiming to provide  insight into the evolving landscape of rebound myopia management strategies
 
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