FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/10/021538 [Registered on: 07/10/2019] Trial Registered Prospectively
Last Modified On: 05/10/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Atropine eyedrops for treatment of increasing shortsight 
Scientific Title of Study   Low strength Atropine (0.01%) eyedrops for treatment of progressive myopia in children and young adults-A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1218-2599  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abraham Kurian 
Designation  Medical Superintendent and Senior Consultant 
Affiliation  Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum 
Address  Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9847094478  
Fax    
Email  abrahamkurian55@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Abraham Kurian 
Designation  Medical Superintendent and Senior Consultant 
Affiliation  Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum 
Address  Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9847094478  
Fax    
Email  abrahamkurian55@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Abraham Kurian 
Designation  Medical Superintendent and Senior Consultant 
Affiliation  Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum 
Address  Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9847094478  
Fax    
Email  abrahamkurian55@yahoo.in  
 
Source of Monetary or Material Support  
Chaithanya Eye Hospital and Research Institute, Trivandrum 
 
Primary Sponsor  
Name  Dr Abraham Kurian 
Address  Chaithanya Eye Hospital and Research Institute, Trivandrum 
Type of Sponsor  Other [Principal Investigator] 
 
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 Iodine Reghunadhan  Chaithanya Eye Hospital and Research Institute  Comprehensive Ophthalmology, Level 2, Room No:2001
Thiruvananthapuram
KERALA 		 9847104830

iodine_b@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaithanya Eye Hospital & Research Institute 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 
Intervention  Atropine  0.01% Atropine eyedrops HS only in the randomised eye for 1 year 
Comparator Agent  NIL  Other eye is not treated and will be used as the comparator to the treated eye.The eye to be treated will be assigned by randomisation 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Children or Young adults in the age group 5-15 years.
2. Myopic refractive error of spherical equivalent > 1.00D as measured by cycloplegic refraction
3. Astigmatism of <1.50D as measured by cycloplegic refraction
4. Documented progression of myopia
5. Ability to understand and follow the study instructions you receive and likely to be amenable for 1 year followup.
6. Normal ocular health other than refractive error
7. Normal Intraocular pressure (<21 mm Hg)
 
 
ExclusionCriteria 
Details  1. Known Allergy or hypersensitivity to Atropine, Cyclopentolate, Phenyl ephrine or Proparacaine
2. Amblyopia in atleast one eye
3. History of significant cardiac or respiratory illness
4. Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study
5. No previous or current use of contact lenses or bifocals or progressive lenses or other forms of treatment (including Atropine in any strength) for myopia
6. Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Progression of myopia in terms of Spherical equivalent in realtion to baseline  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Change in axial length with respect to the baseline measurement.  1 year 
 
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   Phase 4 
Date of First Enrollment (India)   08/10/2019 
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   Chia A, Chua WH, Wen L, et al. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014;157:451–7 e1. 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;123:391–9.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

STUDY OBJECTIVE   :        To evaluate the efficacy and safety of low strength         atropine eyedrops 0.01% in treatment of progressive myopia in children and young adults 

CLINICAL HYPOTHESIS   :    Low dose atropine (0.01%) eyedrops is effective in preventing or slowing down the progression of myopia in children as well as young adults, with minimal or insignificant side effects.

Single centre, Randomised Controlled Trial ; Parallel arm, Interventional design

The primary outcome will be progression of myopia estimated as the change in spherical equivalent refractive error relative to the baseline. The secondary outcome will be the change in axial length with respect to the baseline measurement.

The ATOM studies established the effect of Atropine in preventing the progression of low to moderate myopia and it was concluded that at low strength of 0.01% the drug showed optimum efficacy with minimal side effects and minimal rebound.

However the study failed to study high myopes (>6 D) and children above 12 years while myopic progression can continue in young adults.

Also the study duration was limited which fails to bring out the persistence of the long term results.

So we designed this study to study the efficacy of low strength Atropine(0.01%) in the Indian population, to assess its efficacy in high myopia and to assess the persistence of the efficacy as well as the safety profile for a longer period. Also we intended to include a higher age group ie upto 15 years (Inclusion age: 5-15 years) which was not included in the ATOM studies.



 
Close