| CTRI Number |
CTRI/2020/09/027728 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Artificial Intelligence solution for screening cataract |
|
Scientific Title of Study
|
Validate an Artificial Intelligence solution (PowerAI) for
diagnosing cataract using a mobile aided imaging system |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaushik Murali |
| Designation |
President Medical Administration |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Main Road , Kundalahalli Gate
Bangalore
KARNATAKA
560037
India |
| Phone |
9739000096 |
| Fax |
|
| Email |
kaushik@sankaraeye.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kaushik Murali |
| Designation |
President Medical Administration |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Main Road , Kundalahalli Gate
KARNATAKA
560037
India |
| Phone |
9739000096 |
| Fax |
|
| Email |
kaushik@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaushik Murali |
| Designation |
President Medical Administration |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Main Road , Kundalahalli Gate
KARNATAKA
560037
India |
| Phone |
9739000096 |
| Fax |
|
| Email |
kaushik@sankaraeye.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Varthur Main Road, Bangalore 37 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kaushik Murali |
Sankara Eye Hosptial |
Varthur Main Road, Kundlahalli Gate, Bangalore -37
Bangalore
KARNATAKA |
08028542727
kaushik@sankaraeye.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Analysis of mobile image of lens of the eye using Ai |
Diagnosis of Cataract, pseudophakia or clear lens by the Ai platform would be compared to an ophthalmologist grading of the lens of the eye with LOCS3 grading. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Any cataract
Pseudophakia
Aphakia
Clear Lens |
|
| ExclusionCriteria |
| Details |
Corneal Opacity
nystagmus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ability to Diagnose Cataract in images captured |
on presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
12/09/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Using an Artificial Intelligence algorithm we are aiming at creating a serviceable option to improve clinical workflow of cataract’s diagnosis in the background of large-population screening (community screening).This will be achieved by using a smartphone and capturing an image of the eye. The Ai algorithm would be used to identify cataract , normal eye and pseudophakia/aphakia. This would be compared with a slit lamp examination to identify the presence of cataract. The study looks to compare the ability of a Ai based prediction of a photograph of the eye to help identify cataracts in the study population. |