| CTRI Number |
CTRI/2024/12/078737 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Profile of Corneal Ulcers in Patients Attending a Tertiary Eye Care Centre in a Rural Population |
|
Scientific Title of Study
|
Clinical Profile of Corneal Ulcers Among Patients Attending A Tertiary Eye Care Centre in A Rural Area |
| 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 Shubhangi Singh |
| Designation |
Junior Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Ophthalmology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8433257213 |
| Fax |
|
| Email |
shubhangi1995singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Misra |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Ophthalmology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8787052824 |
| Fax |
|
| Email |
vandana.optimist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gireesh Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Ophthalmology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9309825171 |
| Fax |
|
| Email |
gireeshmishra1960@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 218 Department of Ophthalmology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur, Uttar Pradesh Pin Code 242307 India |
|
|
Primary Sponsor
|
| Name |
Dr shubhangi Singh |
| Address |
Room No 218 Department of Ophthalmology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur |
| 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 Shubhangi Singh |
Varun Arjun Medical College and Rohilkhand Hospital |
Room No 218 Department of Ophthalmology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH |
8433257213
shubhangi1995singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Varun Arjun Medical College ,Banthra,Shahjahanpur,uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H183||Changes of corneal membranes, |
|
|
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 |
Patients age 18yrs to 80 yrs presenting to the tertiary eye care center with presenting corneal ulcer.
Medical records with complete demographic and clinical information available for analysis.
|
|
| ExclusionCriteria |
| Details |
Patients with corneal ulcers due to systemic conditions, such as autoimmune diseases or vasculitis.
Patients with corneal ulcers stemming from pre-existing ocular conditions, including corneal dystrophies or degenerations.
Patients with corneal ulcers resulting from iatrogenic causes, such as surgical complications.
Patients with incomplete medical records or missing key demographic or clinical information necessary for analysis.
Patients with corneal ulcers who have received treatment at another healthcare facility prior to presentation at the designated tertiary eye care center.
Uncooperative/mentally retarded patients or those who refuse to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence, risk factors, and treatment outcomes among patients in a rural tertiary eye care center. |
In 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating specialized eye care accessibility, identifying rural-specific challenges, influencing healthcare policies, and developing tailored protocols to reduce corneal ulcer burden |
In 1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/01/2025 |
| 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="1"
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
|
This study examines the clinical profile of corneal ulcers among patients in a rural tertiary eye care center, focusing on prevalence, risk factors, and treatment outcomes. By addressing unique challenges in rural settings, it aims to guide targeted interventions, improve patient education, and influence healthcare policies. The findings will support the development of tailored treatment protocols and preventive strategies to reduce the burden of corneal ulcers in rural populations. |