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CTRI Number  CTRI/2021/01/030462 [Registered on: 14/01/2021] Trial Registered Prospectively
Last Modified On: 06/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Device 
Study Design  Other 
Public Title of Study   Dryness of Eye prediction by using a android mobile phone 
Scientific Title of Study   Dry Eye Prediction using Smartphones 
Trial Acronym  Tear Film 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAnand Balasubramaniam 
Designation  Senior Consultant 
Affiliation  Sankara Eye Hospital 
Address  Sankara Eye Hospital, Varthur Main road, Kundalahalli gate, Bengaluru-560037.
Sankara Eye Hospital, Varthur Main road, Kundalahalli gate, Bengaluru-560037.
Bangalore
KARNATAKA
560037
India 
Phone  9480587037  
Fax    
Email  moksha_abs@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DrAnand Balasubramaniam 
Designation  Senior Consultant 
Affiliation  Sankara Eye Hospital 
Address  Sankara Eye Hospital, Varthur Main road, Kundalahalli gate, Bengaluru-560037.
Sankara Eye Hospital, Varthur Main road, Kundalahalli gate, Bengaluru-560037.
Bangalore
KARNATAKA
560037
India 
Phone  9480587037  
Fax    
Email  moksha_abs@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DrAnand Balasubramaniam 
Designation  Senior Consultant 
Affiliation  Sankara Eye Hospital 
Address  Room No, 29 B, Cataract, Cornea and Refractive services Ground Floor, Sankara Eye Hospital, Varthur Main Road, Kundalahalli gate, Bangalore-560037,Karnataka.
Sankara Eye Hospital, Varthur Main road, Kundalahalli gate, Bengaluru-560037.
Bangalore
KARNATAKA
560037
India 
Phone  9480587037  
Fax    
Email  moksha_abs@yahoo.co.in  
 
Source of Monetary or Material Support  
Microsoft Research Pvt Ltd 
 
Primary Sponsor  
Name  Microsoft Research Pvt Ltd 
Address  Microsoft, Microsoft Signature Building, Intermediate Ring Rd, Embassy Golf Links Business Park, Domlur, Bengaluru, Karnataka 560071 
Type of Sponsor  Research institution 
 
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 
DrAnand Balasubramaniam  Sankara Eye Hospital  Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore-560037, Karnataka, India
Bangalore
KARNATAKA 
9480587037
-
moksha_abs@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Keratoconus and Dry eye 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Only patients with dry eye condition and healthy eye can participate in this study. The patient must not have any other eye condition(s) except dry eye. 
 
ExclusionCriteria 
Details  The patient with any other eye condition(s) except dry eye. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
aim to develop an end-to-end system to estimate lipid layer thickness, NIBUT (non-invasive tear break up time), TMH (tear meniscus height) and blink dynamics from input images and videos of the eye (20-60 seconds long) captured using smartphones.   Estimation of Dry Eye Parameters using smart phone 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the acquired values from the smart phone device with the standardised lipiview system  Estimation of Dry Eye Parameters using smart phone 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   20/01/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title: Dry Eye Prediction using Smartphones

PI: Dr. Anand Balasubramaniam, Dr. Pallavi Joshi, Dr. Kaushik Murali (Sankara Eye Hospital)

PI: Mohit Jain, Nipun Kwatra, Akshay Nambi (Microsoft Research)

 

Short description

To develop an end-to-end system for dry eye prediction from input images and videos of the eye captured using smartphones.

 

Background

Dry eye is one the most widespread eye diseases, affecting 8% of the global population. It is caused by decreased quantity/quality of tears. With the increasing smartphone penetration, developing world population sees dry eye disease as an emerging threat -- 275 million people in India are expected to be affected by 2030. Even rural India is likely to see 17 million new patients every year.

 

There are several tests to detect dry eye, such as Schirmer’s test, Ocular Staining test, Tear Break Up Time (TBUT) test and LipiView test. Schirmer’s test measures the quantity of tear production, Ocular Staining test determines ocular surface health associated with insufficient tear flow and excessive dryness using rose bengal and/or lissamine green staining, and TBUT test measures the quality of tear film stability using fluorescein sodium strip. Johnson & Johnson LipiView device determines dryness in the eye, by recording 19.1 seconds video of each eye and using color interferometry to determine lipid layer thickness.

 

Our Plan

In this project, we aim to develop an end-to-end system to estimate lipid layer thickness, NIBUT (non-invasive tear break up time), TMH (tear meniscus height) and blink dynamics from input images and videos of the eye (20-60 seconds long) captured using smartphones. As part of the data collection, for each participant, we will collect pairwise video data – using LipiView and using our smartphone setups – in different conditions, including after washing eye with cold water and after watching a 5-mins video with minimal blinks. Two different smartphone setups will be used: (a) two-phone setup for estimating lipid layer thickness and blink dynamics, and (b)mire-based setup: for estimating NIBUT and TMH (as discussed in the slide deck). We will also be collecting Schirmer’s test, Ocular Staining test and TBUT test data. The data after removing all the PII (personally identifiable information) will be used to evaluate our proposed approach of estimating lipid layer thickness compared to the gold standard LipiView device.

 

For details, please refer the attached slide deck.

 

Other details

+ Sample size: Overall 200 dry eye patients and 200 healthy eye patient, over multiple phases.

+ Inclusion/exclusion criteria: Only patients with dry eye condition and healthy eye can participate in this study. The patient must not have any other eye condition(s) except dry eye.

+ Repeat Test: Yes, after watching a pre-selected YouTube video for 5 mins with minimal blinks, after washing eyes with cold water, after using Refresh Tears, and after one hour.

 
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