| CTRI Number |
CTRI/2025/10/095518 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Eye Care Made Easy: The Smart Eye Camera Advantage |
|
Scientific Title of Study
|
Effectiveness of screening using Smart Eye Camera a handheld slit lamp device |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Gajiwala |
| Designation |
Superintendent |
| Affiliation |
Divyajyoti Trust |
| Address |
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Gajiwala |
| Designation |
Superintendent |
| Affiliation |
Divyajyoti Trust |
| Address |
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Gajiwala |
| Designation |
Superintendent |
| Affiliation |
Divyajyoti Trust |
| Address |
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Divyajyoti Trust |
| Address |
Divyajyoti Trust, Tejas Eye Hospital, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India |
| Type of Sponsor |
Other [NGO] |
|
|
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 |
| Dr Uday Gajiwala |
Divyajyoti Trust |
Divyajyoti Trust, Tejas Eye Hospital, Building A Ground Floor A-06, At and Po Amalsadi, Ta. Mandvi, Dist. Surat, Gujarat. India
Surat
GUJARAT |
02623221180
divyajyoti.icare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Divyajyoti Trust Tejas Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H342||Other retinal artery occlusions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above the age of 40 years residing in Umarpada taluka
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Eye care service at the door steps of community
|
at baseline and 1 day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="15000"
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)
|
13/10/2025 |
| 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 Yet Recruiting |
| 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
|
There are 26000 Ophthalmologists in
India. BUT 80% are in cities,
70%
of the population of India still resides in villages, Access to
eye care is a problem for rural populace., We don’t
have enough paramedical workers either – to reach the rural population close to
their doorsteps.Rural poor
illiterate community does not even avail the facilities at vision centres, Need
is
to reach out to them closer to the doorsteps and Technology can
help us in today’s scenario |