| CTRI Number |
CTRI/2021/05/033389 [Registered on: 05/05/2021] Trial Registered Prospectively |
| Last Modified On: |
05/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
AI for cataract identification using smartphone |
|
Scientific Title of Study
|
Validate an Artificial Intelligence solution 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
India
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
Bangalore
KARNATAKA
India
Bangalore
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
Bangalore
KARNATAKA
India
Bangalore
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
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kaushik Murali |
Sankara Eye Hospital |
Pediatric department, room no 24/Ophthalmology division.
Sankara Eye Hospital Varthur Main Road ,Kundalahalli Gate
Bangalore
KARNATAKA |
9739000096
kaushik@sankaraeye.com |
|
|
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 |
Pseudophakia and Clear Lens |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Ages above 50 years
All types of cataract
Pseudphakia
CLear lens |
|
| ExclusionCriteria |
| Details |
Nystagmus
Corneal opacity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Detection of cataract with visual acuity 6/18 in general population using smartphone based images of the eye
|
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptance of AI based screening among patients at outreach camps |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="914"
Sample Size from India="914"
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)
|
10/05/2021 |
| 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="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)?
Response - NO
|
|
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 an AI based prediction of a photograph of the eye to help identify cataracts in the study population. |