| CTRI Number |
CTRI/2026/03/106598 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Novel outreach camp with incorporating digital data management system |
|
Scientific Title of Study
|
Aravind-Orbis Novel Outreach Camp Model |
| Trial Acronym |
CARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dayakar Yadalla |
| Designation |
Camp Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No. 13 A BLOCK First floor Cuddalore main road Thavalakuppam Pondicherry PONDICHERRY 605007 India |
| Phone |
09786396129 |
| Fax |
|
| Email |
dayakar.dr@aravind.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dayakar Yadalla |
| Designation |
Camp Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No. 13 A BLOCK First floor Cuddalore main road Thavalakuppam
PONDICHERRY 605007 India |
| Phone |
09786396129 |
| Fax |
|
| Email |
dayakar.dr@aravind.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Dayakar Yadalla |
| Designation |
Camp Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No. 13 A BLOCK First floor Cuddalore main road Thavalakuppam
PONDICHERRY 605007 India |
| Phone |
09786396129 |
| Fax |
|
| Email |
dayakar.dr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Orbis International, 307B/1, Solitaire Plaza, MG Road
Near Guru Dronacharya Metro Station, Gurugram, Haryana 122002 |
|
|
Primary Sponsor
|
| Name |
Orbis |
| Address |
Orbis International, 307B/1, Solitaire Plaza, MG Road
Near Guru Dronacharya Metro Station
Gurugram, Haryana 122002 |
| Type of Sponsor |
Other [Non profit organization] |
|
|
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 Dayakar Yadalla |
Aravind Eye Hospital |
Cuddalore main road
Thavalakuppam
Aravind Eye Hospital Pondicherry PONDICHERRY |
0413-2619200
dayakar.dr@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H538||Other visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The project will cover individuals
of all age groups attending the outreach camps at
eight districts in Tamil Nadu: Cuddalore,Villuppuram, Tiruvannamalai,Nagapattinam, Kallakurichi,Ariyalur, Mayiladuthurai, and Thiruvarur
|
|
| ExclusionCriteria |
| Details |
1. The participant not willing to follow up in the base hospital.
2. The participant from other districts that is apart from 8 districts attend the camp |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall, a model is developed that can be replicated and scaled across the state and India
Improve acceptance for cataract surgery from 75% to 90%
Improve referral compliance for eye diseases other than cataract from 21% to 60%
Improve post-operative follow-up rate at one month from 80% to 90%
Post-intervention Quality of Life assessment for patients operated from 10% of camps
|
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improve acceptance for cataract surgery from 75% to 90%
Improve referral compliance for eye diseases other than cataract from 21% to 60%
Improve post-operative follow-up rate at one month from 80% to 90%
Post-intervention Quality of Life assessment for patients operated from 10% of camps
|
3 years |
|
|
Target Sample Size
|
Total Sample Size="100000" Sample Size from India="100000"
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)
|
30/03/2026 |
| 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="3" Months="0" Days="0" |
|
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 the leading cause of
avoidable blindness in India, with its impact expected to increase
significantly due to the country’s rapidly aging population and unmet need for
eye care services. Chronic eye conditions and posterior segment diseases are
also contributing to the rising burden of visual impairment. Access to timely
and quality eye care is highly unequal, particularly in rural areas, where most
of the population resides with a very limited number of caregivers. Outreach
eye camps are the vital entry point for nearly 46% of individuals accessing
services for the first time through these camps. However, most outreach efforts
lack standardized protocols for early detection, referral, follow-up, and
continuity of care, resulting in missed treatment opportunities and poor
outcomes. These institutional gaps are compounded by low community awareness,
economic barriers, and the perception that vision loss is a normal part of
aging, which delays health-seeking behavior. Additionally, lack of integration
with the health system and tertiary facilities often delays timely referral and
post-operative care.
To address these challenges, a
structured, scalable community outreach model is proposed. Integrating
technology, digital systems, and community-based approaches, the model will be implemented
in eight underserved districts of Tamil Nadu—Cuddalore, Viluppuram,
Tiruvannamalai, Nagapattinam, Kallakurichi, Ariyalur, Perambalur, and
Thiruvarur. Sixty outreach camps will be conducted annually using portable
diagnostic devices (e.g., handheld slit lamps, vision screeners,
autorefractors), simulation glasses for patient education, and digital data management
system for real-time patient registration, tracking, and follow-up. Trained
local teams, including paramedical ophthalmic personnel, counselors, and
outreach coordinators, will lead implementation, with a strong focus on
community engagement and behavior change communication (BCC) strategies such as
group education sessions and targeted counseling to empower the community and
caregivers. In addition to addressing cataract, the model will screen for and
support long-term management of chronic conditions, positioning camps as
platforms for comprehensive primary eye care. The model will also build
strategies to address gender inequality, as women are 35 percent more likely to be
blind and 27 percent less likely to undergo cataract surgery than men. Despite
comprising 53% of outreach attendees, they often face delayed diagnosis and
poorer outcomes. Gender-responsive strategies will be embedded throughout the
model to improve women’s access and health-seeking behavior, helping to close
this gap.
This model will be further expanded
across Orbis partner hospitals’ network in Andhra Pradesh, Puducherry, and
other states. In addition, efforts will be made to integrate it within the
network of 300+ eye care institutions of the Orbis partner hospital in India.
Exposure to this model will be included in the training programs for Eye Health
Outreach Managers, Program Managers, and Project Managers. This will also
create opportunities for adapting this model across other eye care facilities
within India and abroad. By bridging gaps in detection, referral, treatment
adherence, and follow-up, while strengthening local capacity and raising
community awareness, this model aims to reduce avoidable blindness in India by
developing and establishing a replicable and scalable model of a novel outreach
camp that extensively uses information technology and portable advanced
diagnostic devices to improve early identification of cataracts and other
chronic eye conditions. Its integrated, people-centered, and technology-driven
design offers a practical, scalable approach to delivering high-quality,
equitable eye care and advancing progress toward universal eye health coverage
in India. |