| CTRI Number |
CTRI/2024/04/065473 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate performance of AI-based cataract screening solution via smartphones |
|
Scientific Title of Study
|
Pilot Study to Validate Diagnostic Accuracy in
screening of cataract patients using Smartphone based Application |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddharam S jani |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Telangana. |
| Address |
AIIMS Bibinagar Hyderabad Metropolitan Region, Telangana -508126 COSCO Registration No. ECR/1596/lnstffG/2021
OHR Provisional Registration No. EC/NEW/INST/2021/1893
Hyderabad
TELANGANA
508126
India |
| Phone |
9962171725 |
| Fax |
|
| Email |
drsiddharam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivedita Tiwari |
| Designation |
Director |
| Affiliation |
NexFitzap Pvt.Ltd |
| Address |
D Labs Incubator Association, A, Rd Number 6, ISB Campus, Gachibowli, Hyderabad, Telangana 500111
D Labs Incubator Association, A, Rd Number 6, ISB Campus, Gachibowli, Hyderabad, Telangana 500111
Hyderabad
TELANGANA
500032
India |
| Phone |
07980697009 |
| Fax |
|
| Email |
Nivedita.tiwari@Logy.AI |
|
Details of Contact Person
Public Query
|
| Name |
Nivedita Tiwari |
| Designation |
Director |
| Affiliation |
NexFitzap Pvt.Ltd |
| Address |
D Labs Incubator Association, A, Rd Number 6, ISB Campus, Gachibowli, Hyderabad, Telangana 500111
D Labs Incubator Association, A, Rd Number 6, ISB Campus, Gachibowli, Hyderabad, Telangana 500111
TELANGANA
500032
India |
| Phone |
07980697009 |
| Fax |
|
| Email |
Nivedita.tiwari@Logy.AI |
|
|
Source of Monetary or Material Support
|
| Nex Fitzap Pvt Ltd, D Labs Incubator Association, A, Rd Number 6, ISB Campus, Gachibowli, Hyderabad, Telangana India 500111 |
|
|
Primary Sponsor
|
| Name |
Nex Fitzap Pvt.Ltd |
| Address |
D Labs Incubator Association, A, Rd Number 6, ISB Campus, Gachibowli, Hyderabad, Telangana 500111 |
| Type of Sponsor |
Other [Startup/Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nex Fitzap PvtLtd |
D Labs Incubator Association, A Rd Number 6, ISB Campus Gachibowli Hyderabad Telangana 500111 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siddharam S Janti |
All India Institute of Medical College BB nagar Telangana |
Department of Ophthalmology, AIIMS Bibinagar Hyderabad Metropolitan Region, Telangana -508126 COSCO Registration No. ECR/1596/lnstffG/2021
OHR Provisional Registration No. EC/NEW/INST/2021/1893
Hyderabad
TELANGANA |
9962171725
drsiddharam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Al/MS BBN-IEC) AIIMS Bibinagar Hyderabad Metropolitan Region, Telangana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
patient with above age group 45years and willing to consent in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimating the accuracy of detection for age- related cataract with AI based cataract screening solution developed by Nex-Fitzap Ltd on smartphones for a sample of 500 patients. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimate the prevalence of age related cataract in patients more than 45 years |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
05/05/2024 |
| 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="0"
Days="6" |
|
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
|
Cataract is a condition in which the lens of the eye becomes cloudy. Symptoms include blurred, cloudy, or double vision; sensitivity to light; and difficulty seeing at night.
Without treatment, cataracts can cause blindness. There are many different types and causes of cataracts. They may occur in people of all ages but are most common in the elderly.
Most cataracts are caused by regular changes in eyes as one gets older. When young, the lens in the eye is clear. Around age 40, the proteins in the lens of your eye start to break down and clump together.
This clump makes a cloudy area on your lens — or a cataract.
Today, Cataract is responsible for 70% of blindness in India and 50% globally
Yet with only 10,000+ ophthalmologists across India, the biggest reason for avoidable blindness is due to lack of awareness and early screening.
This brings. the need for a noble AI enabled cataract screening solution developed by Logy.AI ( NexFitzap Private Limited) for remotely accessible, cost and time efficient solution.
In multiple trials, the accuracy of detecting age -related cataract from the phone images has been seen to be 92%+ accurate by the AI solution.
Objective of the study is establishing the accuracy of the trial on a larger sample size. |