| 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
|
|
|
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
|
|
|
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 |