| CTRI Number |
CTRI/2025/10/096391 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop and test a new screening tool (Ped-STAR) and lifestyle checklist to help detect and manage dry eye disease in children |
|
Scientific Title of Study
|
Development and Effectiveness Evaluation of a Child Specific Dry Eye Screening Questionnaire (csdesq) and Daily Lifestyle Management Checklist : An Approach for Screening and Preventing Paediatric Dry Eyes |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC-NEW-INST-2022-PB-0081-V1.0-28-10-2024 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Singh |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab |
| Address |
Room No. 401, 4th Floor, Galileo Block, Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab
Patiala
PUNJAB
140401
India |
| Phone |
6206764481 |
| Fax |
|
| Email |
singh.smita@chitkara.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Astha Mishra |
| Designation |
PhD Scholar |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab |
| Address |
Room No. 408, 4th Floor, Galileo Block, Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab
Patiala
PUNJAB
140401
India |
| Phone |
7814476842 |
| Fax |
|
| Email |
mishraastha19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Astha Mishra |
| Designation |
PhD Scholar |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab |
| Address |
Room No. 408, 4th Floor, Galileo Block, Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab
Patiala
PUNJAB
140401
India |
| Phone |
7814476842 |
| Fax |
|
| Email |
mishraastha19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Name of Source: Kapil Eye Hospital, Ambala
Address: 240, Vivek Vihar, Ambala City, Haryana, 134003, India
Department: Ophthalmology
Support Provided: Provision of clinical facilities and access to participants for data collection. No monetary funding was provided. |
|
|
Primary Sponsor
|
| Name |
Chitkara Uinversity |
| Address |
Chitkara School of Health Sciences,
Galileo Block, 4th Floor, Room No. 408,
Chitkara University,
Rajpura, Punjab, India
Pin 140401 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Gupta |
Kapil Eye Hospital |
Room No. 3, Department of Pediatric Ophthalmology, 240 Vivek Vihar Ambala City, Haryana
Ambala
HARYANA |
9671400860
amitg.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITTEE CHITKARA UNIVERSITY, PUNJAB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pediatric Dry Eye Screening (among 6 to 12 years children) |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 to 12 years who visit the eye hospital.
2. Informed consent obtained from parents or guardians (parents/guardians should be willing to spend sufficient time with their child).
3. Children and their parents who can understand English or Hindi and are able to respond to the questionnaire.
4. Both child and parent are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Children with significant cognitive or developmental issues or the presence of other significant eye diseases that could interfere with the diagnosis or assessment of dry eye.
2. History of other ocular surface diseases that could confound the diagnosis of dry eye.
3. Current use of contact lenses, as this can alter tear film stability.
4. Ocular surgery or trauma within the last 3 months.
5. Use of medications known to affect tear production or the ocular surface.
6. Inability to obtain parental consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Baseline dry eye symptom score in children (6–12 years) assessed using a study-specific screening questionnaire (Tool) |
Baseline (pre-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in dry eye symptom score after following the lifestyle management checklist, assessed at 3 weeks post- Checklist intervention |
Follow-up at 3 weeks post-Checklist intervention |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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)
|
01/11/2025 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to develop and evaluate a Child-Specific Dry Eye Screening Questionnaire (CSDESQ) and a Daily Lifestyle Management Checklist for children aged 6–12 years. The primary objective is to create and validate a screening tool (PeD-STAR) for early detection of pediatric dry eye. Children screening positive will receive a lifestyle management checklist, and changes in symptom scores will be evaluated after 3 weeks. The study focuses on early screening and prevention of pediatric dry eye through lifestyle-based, non-pharmacological interventions...........Recruitment ongoing as per approved protocol. No changes since registration. |