| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Keratoconus and Dry eye |
|
|
Intervention / Comparator Agent
|
|
|
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. |