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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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