FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017441 [Registered on: 05/02/2019] Trial Registered Prospectively
Last Modified On: 20/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Prevalence and outcome of treatment of lazy eye 
Scientific Title of Study   Prevalence of amblyopia in Children less than 18 years attending a tertiary care hospital and outcome of amblyopia therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuj Harish Kodnani 
Designation  Postgraduate Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal
701, Regal Woods, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9428974800  
Fax    
Email  anuj_kodnani@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Pai H 
Designation  Professor and Head of Unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9428974800  
Fax    
Email  pai.vijaya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vijaya Pai H 
Designation  Professor and Head of Unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9428974800  
Fax    
Email  pai.vijaya@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Udupi, Karnataka - 576104 
 
Primary Sponsor  
Name  Dr Anuj Harish Kodnani 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal 
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 Anuj Harish Kodnani  Kasturba Medical College and Hospital  Department of Ophthalmology, Kasturba Medical College, Manipal
Udupi
KARNATAKA 		 9428974800

anuj_kodnani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H530||Amblyopia ex anopsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All cases of amblyopia including newly diagnosed cases as well as cases undergoing treatment of amblyopia. 
 
ExclusionCriteria 
Details  1.) Children who have discontinued treatment from the hospital in between the study period or who did not have minimum follow-up of 3 months.
2.) Cases whose parents do not give consent for study.
3.) Mentally challenged patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The prevalence of amblyopia analysed by taking the numerator as the number of amblyopia cases within the target age group and the denominator as the total number of children who visited the OPD in the same age group in the thesis study period.  same day/one day 
 
Secondary Outcome  
Outcome  TimePoints 
Initial visual acuity and visual acuity after 3 to 6 months of follow up.  same day/one day 
 
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)   10/02/2019 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Amblyopia, the leading cause of monocular vision impairment in children, is caused by inadequate stimulation of the visual system during the sensitive periods of visual development in childhood. A difference in best corrected visual acuity of two Snellen lines or more (or more than one log unit) is indicative of amblyopia. Bilateral refractive amblyopia is defined as vision <6/12 best-corrected in the presence of ≥ +4.00D and/or ≥ 2.00D astigmatism in each eye. Strabismus, cataract and anisometropia are well known causes of amblyopia with strabismic amblyopia being the most common type. Onset of amblyopia is generally in early life typically before the age of 6 years. Treatment regimens include spectacles, patching, and/or atropine penalization.The aim is to study the prevalence of amblyopia in children less than 18 years of age and to study the outcome of patching therapy in amblyopia. All cases of amblyopia coming to the department of ophthalmology in Kasturba Hospital, Manipal on OPD basis including newly diagnosed cases as well as cases undergoing treatment of amblyopia are included in the study. The cases of amblyopia for study will be given treatment of patching which is the standard of care. Those who are willing for regular follow up and complying to the instructions will be followed up for treatment effect. Visual acuity will be noted and measured according to age appropriate method during each visit. Improvement in vision and compliance to patching will be noted. 
Close