| 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
|
|
|
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
|
|
|
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
|
|
|
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 |