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CTRI Number  CTRI/2021/07/035054 [Registered on: 22/07/2021] Trial Registered Prospectively
Last Modified On: 13/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Mixed Methods Study 
Study Design  Other 
Public Title of Study   Development and Validation of Paediatric Ocular Dryness Symptom (PODS) questionnaire 
Scientific Title of Study   Development and Validation of Paediatric Ocular Dryness Symptom (PODS) questionnaire 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rinu Thomas 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  8248507216  
Fax    
Email  rinu.thomas@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Rinu Thomas 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  8248507216  
Fax    
Email  rinu.thomas@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Swetha R 
Designation  M.Optom Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9789979028  
Fax    
Email  swetha.chandran304@gmail.com  
 
Source of Monetary or Material Support  
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka - 576104 
 
Primary Sponsor  
Name  Rinu Thomas 
Address  Dept of optometry MCHP MAHE 
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 
Ms Rinu Thomas  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education  Optometry Preclinic 4th Floor, Department of Optometry, Manipal College of Health Professions, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA 
8248507216

rinu.thomas@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children studying in English Medium Schools from 1st standard to 12th standard will be included in the study.  
 
ExclusionCriteria 
Details  Excluded all schools which are not english medium 
 
Method of Generating Random Sequence    
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development and Validation of PODS Questionnaire  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between screen time usage and dry eye symptoms in pediatric population  2 years 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   24/07/2021 
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="2"
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  

DEVELOPMENT AND VALIDATION OF PAEDIATRIC OCULAR DRYNESS SYMPTOM (PODS) QUESTIONNAIRE

 

Dry eye is a multifactorial disease of both the tears and ocular surface.  It results in symptoms of discomfort, visual disturbance, and tear film instability with some potential damage to the ocular surface. The use of digital devices and technology has increased exponentially during the 20th century and with the advent of the COVID-19 pandemic. Most schools and institutions have resorted to online and digital modes of classes and learning with 36.9% of children using digital devices for more than 5 hours compared to 1.8% of children who were using before the COVID era. Due to this extensive time, which is being spent on digital devices, children are prone to experiencing the symptoms of dry eye that need to be assessed. The purpose of this study was to develop and validate the Paediatric Ocular Dryness Symptom (PODS) questionnaire specific to the paediatric population.

Methodology:

A five phased process will be adopted to develop and validate the PODS questionnaire.

1. Item Development and Instrument Design: This involves the identification of various content dimensions which needs to be added in the questionnaire and sampling of items under each dimension leading to the development of the first version of PODS questionnaire.

2. Content validation: The questions assimilated through the process of instrument construction will be distributed to the experts in the field of Optometry and Ophthalmology and they will be asked to grade the questions based on the relevance, clarity, and essentiality of the questions with respect to the study objective. Following the process of expert opinion, empirical methods will be used to calculate and quantify Content Validity Index (CVI) – Item Level and Scale Level (I-CVI and S-CVI) and Content Validity Ratio (CVR).

3. Face validation: Qualitative face validity will be carried out using the first version of the questionnaire through a direct online cognitive interview with the target population. The target population will include children studying in an English medium school within the age group of 6-18 years corresponding to Ist to XIIth standard of education. Snowball sampling will be used for identifying more children for this phase of validation and Microsoft teams will be used for the online interview process. The quantitative method of face validation will involve allowing the participants to grade the questions in the first version of the questionnaire based on its importance to calculate the item impact score (IIS).

4. Criterion Validity: Criterion validity will be done using two methods – Concurrent and Predictive validity methods. Concurrent validation would involve grouping children based on their diagnosis of dry eye and allowing them to complete the PODS questionnaire. Correlation between the diagnosis of dry eye and PODS questionnaire score will be used to establish the concurrent validity of the questionnaire.

A separate questionnaire to assess the screen time in children would also be done following which PODS will be given to the children. Correlation between the screen time as a predictor of dry eye symptoms would be the method used for the predictive validation process.

5. Reliability and repeatability assessment for the questionnaire.

Outcome:

1. Development and Validation of PODS questionnaire

2. Correlation between screen time and dry eye symptoms in children


 
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