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CTRI Number  CTRI/2024/01/061687 [Registered on: 22/01/2024] Trial Registered Prospectively
Last Modified On: 19/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To find out the environmental Impact of patients visiting Base Hospital as compared to primary eye care centers(Vision centers) 
Scientific Title of Study   Environmental Assessment of Community-Based Vision Centres Vs. Referral Centre Visits 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Kavitha 
Designation  Head of the Department Glaucoma Services 
Affiliation  Aravind Eye Hospital 
Address  First floor, Room No. 21, Aravind Eye Hospital
Cuddalore main road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India 
Phone  9894611575  
Fax  -  
Email  kavitha@aravind.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Kavitha 
Designation  Head of the Department Glaucoma Services 
Affiliation  Aravind Eye Hospital 
Address  Room No.21, First floor, Aravind Eye Hospital
Cuddalore main road, Thavalakuppam Pondicherry
Pondicherry
PONDICHERRY
605007
India 
Phone  9894611575  
Fax  -  
Email  kavitha@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Dr S Kavitha 
Designation  Head of the Department Glaucoma Services 
Affiliation  Aravind Eye Hospital 
Address  Room No. 21, First floor, Aravind Eye Hospital
Cuddalore main road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India 
Phone  9894611575  
Fax  -  
Email  kavitha@aravind.org  
 
Source of Monetary or Material Support  
University of Michigan Ann Arbor, MI USA 
 
Primary Sponsor  
Name  University of Michigan 
Address  Kellogg Eye Center, University of Michigan Ann Arbor, MI, USA email ID: mirzania@med.umich.edu  
Type of Sponsor  Research institution and hospital 
 
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 
DrS Kavitha  Aravind Eye Hospital  Ground Floor, Out Patient Department Cuddalore main road Thavalakuppam Pondicherry. And Vision Centers attached to Aravind Eye Hospital, Pondicherry
Pondicherry
PONDICHERRY 
9894611575
-
kavitha@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: Z048||Encounter for examination and observation for other specified reasons, (2) ICD-10 Condition: Z000||Encounter for general adult medical examination,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria (Vision centre participant)
1.Adult new patients attending their first synchronous telemedicine visits at a Vision Centre associated with Aravind Eye Hospital, Pondicherry
2.Patients residing in districts surrounding Pondicherry - Cuddalore, Villupuram and Kallakurichi which are also VC serviced areas.

Inclusion criteria (Base hospital participant)

1.Adult new patients attending their first ophthalmic visit at Aravind Eye Hospital (AEH) in Pondicherry
2.Patients residing in districts surrounding Pondicherry - Cuddalore, Villupuram and Kallakurichi and within the defined VC service area
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To quantify carbon emissions of Vision center visits versus base hospital visits   Baseline to 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the likelihood of presenting to the base hospital of patients who present to VC & are referred to the base hospital for additional evaluation.

To identify the barriers to presentation to the base hospital for follow-up visits when referred from the Vision centers to the base hospital.
 
Baseline to 3 months 
 
Target Sample Size   Total Sample Size="4848"
Sample Size from India="4848" 
Final Enrollment numbers achieved (Total)= "4838"
Final Enrollment numbers achieved (India)="4838" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/01/2024 
Date of Study Completion (India) 30/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Introduction/Background

Telemedicine is a rapidly progressing field with the potential to improve access to care by overcoming barriers of proximity. Existing literature on telemedicine has demonstrated decreased cost and a favorable perception of telemedicine.1  The efficacy of tele-ophthalmology has been demonstrated in diabetic retinopathy and glaucoma screening.2-6 However, few studies have evaluated the environmental impact of telemedicine visits.7 Teleophthalmology-based vision centers (VC) in rural India provide accessible and affordable eye care to approximately 75,000 to 100,000 people in a radius of 10 kilometers (km)8,9 in each of over 100 VCs attached to Aravind Eye Care System, in south India. In addition to providing accessible and cost-effective primary eye care, VCs save patients a trip to the base hospital (BH), which can cumulatively add to the carbon footprint of healthcare. The Kyoto Protocol identifies six main gases important to climate change out of which carbon dioxide (CO2) is used as the reference gas.10 The total emissions of the activity/product are expressed in the units of CO2 equivalents (CO2eq). The carbon footprint of healthcare is defined by the greenhouse gas emissions resulting from the full life cycle of a product or service.  For ophthalmology outpatient visits, the largest contributors to greenhouse gas emissions are direct emissions from travel and building energy use, and indirect emissions associated with the production, consumption, and disposal of supplies and equipment.11

 Additionally, with the presence of convenient VCs, we believe that patients are more likely to utilize eye care rather than delaying care with resultant visual disability and blindness with costs to the individual, their families, and society.

Aim:

·         To assess the total carbon emission generated by patients presenting 1) first to a VC with synchronous tele-ophthalmology appointment, and 2) first to the base hospital (BH) (Aravind Eye Hospital in Pondicherry) until resolution of the presenting symptoms or 3 months whichever comes earlier.

 

Objectives

Primary objective

·         To quantify carbon emissions of VC visits vs BH visits

Secondary objectives

·         Survey patients who present to a VC and are referred to the BH for additional evaluation for likelihood of attending follow up visit.

·         Survey patients who report low likelihood of follow up to identify barriers to presentation to BH for follow up visits.

 


 
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