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CTRI Number  CTRI/2026/01/101890 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Testing a new smartphone App for detecting Dry Eye Disease intelligence tool 
Scientific Title of Study   Smartphone-based dry eye disease detection: Development and validation of an artificial intelligence tool 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharsan S 
Designation  PhD Research Scholar 
Affiliation  Department of Basic Medical Sciences, Manipal Academy of Higher Education 
Address  Division of Physiology, Department of Basic Medical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India -576104

Udupi
KARNATAKA
576204
India 
Phone  9360249003  
Fax    
Email  dharsan.dbmsmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujatha P Prabhu 
Designation  Associate Professor 
Affiliation  Department of Basic Medical Sciences, manipal Academy of Higher Education 
Address  Division of Physiology, Department of Basic Medical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India -576104

Udupi
KARNATAKA
576104
India 
Phone  7892198255  
Fax    
Email  sujatha.prabhu@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sujatha P Prabhu 
Designation  Associate Professor 
Affiliation  Department of Basic Medical Sciences, manipal Academy of Higher Education 
Address  Division of Physiology, Department of Basic Medical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India -576104

Udupi
KARNATAKA
576104
India 
Phone  7892198255  
Fax    
Email  sujatha.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
Department of Ophthalmology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Division of Physiology, Department of Basic Medical Sciences, Manipal Academy of Higher Education 
School of Computer Engineering, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Dharsan S 
Address  Division of Physiology, Department of Basic Medical Sciences, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrYogish Subraya Kamath  Kasturba Hospital  2nd floor, Eye OPD, Department of Ophthalmology, Kasturba Medical College, Manipal, Karnataka, India - 576104
Udupi
KARNATAKA 
9845308436

yogish.kamath@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 
Healthy Human Volunteers  Individuals without Dry Eye Disease 
Patients  (1) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals with dry eye disease 
 
ExclusionCriteria 
Details  Participants who had a history of LASIK, ocular surgery, corneal disorders or other ocular infections will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A smartphone-based self-screening AI application for dry eye detection  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="1845"
Sample Size from India="1845" 
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)   18/02/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Justification of the study: The current smartphone-based AI models require a clinician and an external attachment for assessment. Currently available smartphone-based applications for DED interpret the results based on blink rate and maximum blink interval, but not based on smartphone-based images. Limited prevalence data are available for the Karnataka region, which varies across different geographic areas and climates. The increasing prevalence of DED in younger individuals, fuelled by prolonged screen time and modern lifestyle habits, highlights the need for early detection strategies. It is essential to evaluate the prevalence of DED and explore its associations with occupational exposure, environmental factors, lifestyle patterns, and systemic comorbidities to better understand its occurrence and clinical severity. Many individuals with DED tend to seek clinical care only after symptoms have developed. This delay could be reduced through a smartphone-based, AI-integrated self-screening application that requires no clinician assistance. This tool would be cost-effective, minimally invasive, and capable of enabling rapid and early detection, facilitating timely management of DED. The ability of individuals to screen themselves conveniently via their smartphones can promote earlier ophthalmology consultations and support better ocular health and overall well-being.

Aim: To develop a smartphone-based artificial intelligence integrated screening tool for detecting dry eye disease

Objective: To develop and validate an AI model to detect dry eye disease and to assess the prevalence and associated factors of DED

Expected outcome of the study: A  smartphone-based self-screening AI application for dry eye detection
 
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