FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/038177 [Registered on: 22/11/2021] Trial Registered Prospectively
Last Modified On: 19/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   New Drug trial in prevention of the progression of myopia in Indian children 
Scientific Title of Study   Safety and efficacy of Atropine 0.01% and 0.05% in prevention of the progression of Myopia in Indian children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddharam S Janti 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of Ophthalmology All India Institute of Medical Sciences ( AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana
Flat no 302 B block Sanjana Malathi Complex Uppal Hyderabad -500039
Hyderabad
TELANGANA
508126
India 
Phone  9962171725  
Fax    
Email  drsiddharam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharam S Janti 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of Ophthalmology All India Institute of Medical Sciences ( AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana
Flat no 302 B block Sanjana Malathi Complex Uppal Hyderabad -500039
Hyderabad
TELANGANA
508126
India 
Phone  9962171725  
Fax    
Email  drsiddharam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddharam S Janti 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of Ophthalmology All India Institute of Medical Sciences ( AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana
Flat no 302 B block Sanjana Malathi Complex Uppal Hyderabad -500039
Hyderabad
TELANGANA
508126
India 
Phone  9962171725  
Fax    
Email  drsiddharam@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bibinagar Hyderabad 
 
Primary Sponsor  
Name  Dr Siddharam S Janti 
Address  Room no 34 Department of Ophthalmology AIIMS Bibinagar , Hyderabad Telangana - 508126 
Type of Sponsor  Other [] 
 
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 Siddharam S Janti  All India institute Medical Sciences Bibinagar Hyderabad  Room no 34 Department of Ophthalmology AIIMS Bibibnagar
Hyderabad
TELANGANA 		 9962171725

drsiddharam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ( AIIMS BBN - IEC) AIIMS Bibinagar Hyderabad Metropolitan Region Telangana  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 
Intervention  atropine 0.01 % and atropine 0.05% eyedrops  prescription of atropine 0.01 % and 0.05 % eye drops once a day in Group A and Group B myopic children 
Comparator Agent  Carboxy methyl cellulose eyedrops - place bo   prescription of CMC eye drops for group C myopic children 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1 )Age of 5 to 16 years
2 ) Myopia – 1D to -6 D
3 )Annual myopic progression of greater than 0.5 D 
 
ExclusionCriteria 
Details  ● Refractive Myopia
● Astigmatism ≥ 1.5 D
● Amblyopia
● 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
● Lack of consent for participating in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Quantitative assessment of change in refractive error before and after treatment of different concentrations of atropine  3 , 6 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) Measurement of axial length before and after treatment of different concentrations of atropine
2 ) Side effects of low concentration of atropine
 		 3 , 6 and 12 months 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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)   24/11/2021 
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="1"
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  
Title of the project:  Safety and efficacy of Atropine 0.01% and 0.05%  in prevention of the progression of Myopia in Indian children

Objective of the study:

 1)    Quantitative assessment of change in  refractive error before and after treatment  of different concentrations of atropine

2)    Measurement of   axial length before and after treatment of different concentrations of atropine 

3 )   Side effects of low concentration of atropine

 Justification for conducting the study

The comparative studies of the use of Atropine 0.01% and 0.05% has its own merits , however the progression of myopia is shown to be less with the use of 0.05% Atropine. There is not sufficient data in the Indian scenario to conclusively state this.

Detailed methodology including study design and outcome measures :

This is an interventional case study will be  conducted between  2021 and  2022  on children with confirmed myopia greater than �’ 1.0 D and less than -6.00D.

The study would take place at All India Institute of Medical Sciences , Bibinagar , Telangana over a period of 1year.

Sample size -  270 of age group 5-16  years. Both males and females will be included in the study .

Considering the pre and post mean (SD) of 0.05,0.01 and placebo groups RE and the between the groups differences, we require 68 study participants to observe statistical significant differences between 0.05 and placebo group and 103 participants for 0.05 and 0.01 atropine groups. However considering the feasibility of the study and the primary objective we will be recruiting 68 study participants in each group. With 20%drop out rate we will enroll 90  study participants in each group

Inclusion criteria : Age of 5 to 16 years with myopia – 1D to -6 D & an annual myopic progression of greater than 0.5 D.

Exclusion criteria :Exclusion criteria :

●      Refractive Myopia

●      Astigmatism ≥ 1.5 D

●      Amblyopia

●      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

●      Lack of consent for participating in the study

 The sample will be divided into three groups . Each group comprising of   90   members . The selection will be random as per randomisation protocol .

Group A : will be provided with Atropine 0.01% eyedrops.

Group B: will be provided with Atropine 0.05% eye drops.

Group c : will be the control group , provided with the placebo ( CMC 0.5%)

 -The candidates for study will be chosen among the patients attending the Ophthalmology OPD at All India Institute of Medical Sciences , Bibinagar. Each candidate will analyzed by measuring the cycloplegic refraction, intraocular pressure measurement,fundus examination,anterior chamber depth,pupillary diameter measurement ,axial length and accommodation amplitude.Cycloplegic refraction will be done by using The autorefractor-keratometer and retinoscopy. Intraocular pressure will be measured using Non contact tonometry. Slit lamp will be used to measure the fundus , pupillary diameter and the anterior chamber depth. Axial length of the eyeball will be measured using A-scan.Accommodation amplitude will be measured using the RAF ruler.

The candidate would be examined on the first day , 12 weeks later , 24 weeks and after 1 year.

At the end the study period , the ,measurements of the cycloplegic refraction , intraocular measurement , fundus examination , pupillary diameter , anterior chamber depth,axial length  and accommodation amplitude will be recorded and compared for Atropine 0.01% and 0.05% separately along with the pharmacological side effects and the compliance of the drugs.  

A questionnaire will be given to the subject and the attendant which contains questions regarding “visual impairment” , “reading difficulty”, “diplopia”, “light sensitivity” or “glare”. Answers will be categorised as “ yes” or “no”. Then a comparison will be drawn between the two doses of the drug and the results will be obtained .

 Timelines:

Activities

Duration

4 months 

Enrolment of children & Randomisation

Every 3 months 

Follow up of children with assessment of progression of refractive error , axial length measurement and reporting of complications of atropine

16 months 

Data acquisition and statical analysis

 

 Data analysis Plan

Data will be entered in Microsoft Excel and will be analysed in SPSS software 21 . Per protocol will be done. The categorical variables will be summarised using frequency and proportions and quantitative variables will be summarised by mean , standard deviation. The significance between the 2 grope will be assessed by Annova test and Bonferroni test . the effect size for the primary outcome variable will be calculated by standardized mean difference. The level of statical significant will be consider as 5%.

 

 
Close