| CTRI Number |
CTRI/2022/11/047169 [Registered on: 10/11/2022] Trial Registered Prospectively |
| Last Modified On: |
08/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study of Vision in Normal and Diabetic Patient Without Diabetic Retinopathy |
|
Scientific Title of Study
|
"Comparison of proportional macular thinning in normal and diabetic patients without diabetic retinopathy in tertiary hospital-cross sectional comparative study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prapti Rathod |
| Designation |
Resident Doctor |
| Affiliation |
Govt Medical College Bhavanagar |
| Address |
Department Of Ophthalmology
New Opd Building
Sir T hospital
Bhavanagar.
23,PG-1, Sir T Hospital
Bhavnagar
GUJARAT
364001
India |
| Phone |
9662286469 |
| Fax |
|
| Email |
prapti.rathod96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Nilesh Parekh |
| Designation |
Head of Department |
| Affiliation |
Govt Medical College Bhavanagar |
| Address |
Department of Opthalmology
New OPD building
Sir T hospital
Bhavanagar.
Department of ophthalmology
bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428408788 |
| Fax |
|
| Email |
drnvparekh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Dhruvil nayak |
| Designation |
Resident Doctor |
| Affiliation |
Govt Medical College Bhavanagar |
| Address |
Department Of Ophthalmology
5 floor new OPD building
Sir T hospital
Bhavanagar
Department of ophthalmology,
bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8511803868 |
| Fax |
|
| Email |
dhruvilnayak96@gmail.com |
|
|
Source of Monetary or Material Support
|
| 5th floor,NEW OPD BUILDING,SIR T HOSPITAL,BHAVNAGAR |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF OPHTHALMOLOGY |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
5th floor department of ophthalmology
Sir T Hospital
Bhavanagr |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Prapti rathod |
NILDEPARTMENT OF OPHTHALMOLOGY
5th floor department of ophthalmology
Sir T Hospital
Bhavanagr |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRPRAPTI RATHOD |
SIR T HOSPITAL,BHAVNAGAR |
DEPARTMENT OF OPHTHALMOLOGY
5th floor
New OPD building
Sir T Hospital
Bhavanagr
Bhavnagar
GUJARAT |
9662286469
prapti.rathod96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| E C commitee Govt Medical College Bhavanagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E133||Other specified diabetes mellituswith ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Normal and Diabetic patients without diabetic retinopathy
40 to 70 years age
|
|
| ExclusionCriteria |
| Details |
Pt having other retinal pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Macular Thinning In Normal Patients And Diabetic Patient Without Diabetic Retinopathy |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HOW MUCH IS THE MACULAR THINNING IN DIABETIC PATIENTS AS COMPARED TO NORMAL PATIENTS |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/11/2022 |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
data will be collected in excel sheet and proper analysis will be done by appropriate statistical test |