| CTRI Number |
CTRI/2025/05/087010 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess Visual Acuity, vision related Quality of Life (QoL) among diabetic retinopathy patients. |
Scientific Title of Study
Modification(s)
|
A descriptive study to assess the Visual Acuity, vision related Quality of Life (QoL) and Patient Reported Outcome Measure (PROM) among patients with diabetic retinopathy with an intent to develop an audio care module. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonia Ravichandran CSR |
| Designation |
MSc Nursing Student |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Porta cabin 2
College of Nursing
All I India Institute of Medical Sciences
NewDelhi
Sri Aurobindo Marg
Ansari Nagar East
New Delhi
South
DELHI
110029
India |
| Phone |
9791414041 |
| Fax |
|
| Email |
soniaravichandran88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Ground floor
Room no 5
College of Nursing
All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Ground floor
Room no 5
College of Nursing
All India Institute of Medical Sciences New Delhi
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute if Medical Sciences
Sri Aurobindo Marg
Ansari Nagar East
NewDelhi
110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Porta cabin 2 College of Nursing
All India Institute of Medical Sciences
New Delhi
110029 |
| 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 |
| Sonia Ravichandran CSR |
All Institute of Medical Sciences |
Ground floor
RPC OPD
AIIMS
Sri Aurobindo Marg
Ansari Nagar East
110029
South
DELHI |
9791414041
soniaravichandran8@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE FOR POST GRADUATE RESEARCH,AIIMS |
Approved |
| Institutional Ethics Committee AIIMS NewDelhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetic patients who attend Retina clinic, AIIMS Delhi.
Patients who consent to participate in the study.
Patients who can read and understand English and Hindi languages.
|
|
| ExclusionCriteria |
| Details |
Type 2 Diabetic patients with significant diabetic related complications, other than Diabetic Retinopathy (DR).
Type 2 diabetic patients with other ocular problems are excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Acuity
Vision related quality of life
Patient Related Quality of Life
|
Visual Acuity - at baseline
Vision related quality of life- at baseline
Patient Related Quality of Life- at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between Diabetic Retinopathy and Visual Acuity.
Association between Diabetic Retinopathy and vision related quality of life.
|
Association between Diabetic Retinopathy and Visual Acuity - at baseline
Association between Diabetic Retinopathy and vision related quality of life - at baseline
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
22/11/2025 |
| 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 Yet Recruiting |
| 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)
|
This descriptive study assessed visual acuity, vision-related Quality of Life (QoL), and Patient-Reported Outcome Measures (PROM) among patients with diabetic retinopathy to develop an audio care module. Data were collected in 200 participants using tools to evaluate visual acuity, QoL, and PROM, highlighting the functional and emotional impact of vision loss. The study revealed varying degrees of vision impairment, significantly affecting patients’ daily living, reading, and mobility. Participants reported challenges in physical and emotional well-being, emphasizing the burden of vision-related disabilities. Findings showed improvements in QoL over time in groups receiving interventions. The research underscores the need for comprehensive care that addresses clinical, functional, and psychological aspects of diabetic retinopathy. A tailored care module based on these findings could improve outcomes, enhance patient well-being, and support better disease management. This study highlights the value of integrating PROM and QoL assessments into routine care for diabetic retinopathy patients. |