| 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 |
|
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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 |
|
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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 |
|
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Primary Sponsor
|
| Name |
Rinu Thomas |
| Address |
Dept of optometry
MCHP
MAHE |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
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Intervention / Comparator Agent
|
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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 |
|
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Method of Generating Random Sequence
|
|
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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 |
|
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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
|
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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 |