| 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
|
|
|
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
|
|
|
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 |
|
|
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.
|