| CTRI Number |
CTRI/2025/11/096769 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Eye screening for people with diabetes, high blood pressure, and age-related eye problems in rural Odisha using a smartphone camera. |
|
Scientific Title of Study
|
Implementation of smart phone-based fundus camera screening for Diabetic Retinopathy, Hypertensive Retinopathy and Age-related Macular Degeneration in rural primary care: a mixed methods study |
| 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 Adyasha Das |
| Designation |
Student |
| Affiliation |
ICMR-RMRCBB |
| Address |
Annex building, MPH department, 2nd floor,ICMR- Regional Medical Research Centre, Chandrasekharpur
Bhubaneswar- 751023, Odisha, India
Cuttack
ORISSA
751023
India |
| Phone |
6372018815 |
| Fax |
|
| Email |
adyasha.301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jaya Singh Kshatri |
| Designation |
Scientist-C |
| Affiliation |
ICMR-RMRCBB |
| Address |
Room No-506,3rd Floor, Annex Building,ICMR-Regional Medical Research Centre
Chandrasekharpur, Bhubaneswar-751023
Odisha, India
Cuttack
ORISSA
751023
India |
| Phone |
9937572685 |
| Fax |
|
| Email |
jsk.icmr@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adyasha Das |
| Designation |
Student |
| Affiliation |
ICMR-RMRCBB |
| Address |
Annex building, MPH division, 2nd floor,ICMR- Regional Medical Research Centre, Chandrasekharpur
Bhubaneswar- 751023, Odisha, India
Cuttack
ORISSA
751023
India |
| Phone |
6372018815 |
| Fax |
|
| Email |
adyasha.301@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayushman Arogya Mandir, Village- B. Turubudi, Block- Digapahandi, CHC Bomkhei, District-Ganjam, Odisha – 761012 |
|
|
Primary Sponsor
|
| Name |
Dr Adyasha Das |
| Address |
Annex building,ICMR- Regional Medical Research Centre, Chandrasekharpur
Bhubaneswar- 751023, Odisha, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Adyasha Das |
Ayushman Arogya Mandir, Village- B. Turubudi |
screening room, Ayushman Arogya Mandir, Village- B. Turubudi, Block- Digapahandi, CHC Bomkhei, District-Ganjam, Odisha – 761012
Ganjam
ORISSA |
6372018815
adyasha.301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR-Regional Medical Research Centre, Bhubaneswar Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, (4) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Training of Community Health Officers for retinal imaging using handheld smartphone-based fundus camera (Remidio Fundus on Phone, Remidio Innovative Solutions Pvt. Ltd., Bengaluru, India |
Community Health Officers (CHOs) will be trained to conduct retinal imaging using a handheld smartphone-based fundus camera (e.g., Remidio Fundus on Phone [FOP] device, Remidio Innovative Solutions Pvt. Ltd., Bengaluru, India) at the Sub-Centre level. After training, CHOs will screen eligible participants (people with diabetes or hypertension) for Diabetic Retinopathy, Hypertensive Retinopathy, and Age-related Macular Degeneration. The captured retinal images will be reviewed by an ophthalmologist for diagnosis and referral as required. The intervention includes training, implementation of screening, and referral linkage for further management. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults aged eighteen years and above with a known diagnosis of hypertension or currently taking antihypertensive medication.
2 Adults aged eighteen years and above with a documented diagnosis of hypertension, defined as:
Stage 1 Hypertension: Systolic blood pressure between one hundred thirty and one hundred thirty-nine millimetres of mercury or diastolic blood pressure between eighty and eighty-nine millimetres of mercury.
Stage 2 Hypertension: Systolic blood pressure of one hundred forty millimetres of mercury or higher, or diastolic blood pressure of ninety millimetres of mercury or higher.
3 Adults aged eighteen years and above with a known diagnosis of type 1 diabetes mellitus for at least five years.
4 Adults aged eighteen years and above with a known or newly diagnosed case of type 2 diabetes mellitus.
5 Newly diagnosed individuals meeting at least one of the following criteria:
Fasting Plasma Glucose of one hundred twenty-five milligrams per decilitre or higher.
Two-hour plasma glucose after seventy-five grams oral glucose load of two hundred milligrams per decilitre or higher.
Random Blood Sugar of two hundred milligrams per decilitre or higher.
Glycated haemoglobin (HbA1c) of six point five percent or higher.
6 Individuals with both diabetes and hypertension will not be included.
7 Adults aged fifty years and above, irrespective of known chronic disease status, for screening of age-related macular degeneration. |
|
| ExclusionCriteria |
| Details |
1 Eyes with media opacities, such as dense cataract, that make it impossible to visualize the retina.
2 Participants already diagnosed and currently undergoing active treatment for retinal conditions, such as those who have previously received laser therapy, intravitreal injections, or retinal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Evidence on Implementation outcomes: acceptability, feasibility, sustainability, fidelity of CHO led smartphone-based DR screening of Hypertensive Retinopathy (HR), and Age-Related Macular Degeneration (ARMD).
•Benefits of the Implementation
•System-level recommendations for scale-up
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/11/2025 |
| 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="0"
Months="3"
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
|
This study aims to evaluate the implementation of smartphone-based fundus camera screening for diabetic retinopathy, hypertensive retinopathy, and age-related macular degeneration in rural primary healthcare settings of Odisha. The objective is to assess the feasibility, acceptability, and integration of this screening method when performed by Community Health Officers at sub centers. The study will use a mixed methods approach including quantitative screening data and qualitative insights from patients, health workers, and other stakeholders. Findings will help identify facilitators, barriers, and system level recommendations for scaling up retinal screening services. |