| CTRI Number |
CTRI/2024/09/074379 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of Colour doppler,Optical Coherence Tomography Angiography ,Fundus Fluorescein Angiography in diabetic retinopathy patients |
|
Scientific Title of Study
|
Evaluation of Ocular perfusion Biomarkers in Diabetic Retinopathy |
| 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 Punita Kumari Sodhi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology Maulana Azad Medical College And Associated Guru Nanak Eye Centre New Delhi
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604414 |
| Fax |
|
| Email |
sodhipunita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali K |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology Maulana Azad Medical College And Associated Guru Nanak Eye Centre New Delhi
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9447864303 |
| Fax |
|
| Email |
anjalikpayyanur7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali K |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology Maulana Azad Medical College And Associated Guru Nanak Eye Centre New Delhi
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9447864303 |
| Fax |
|
| Email |
anjalikpayyanur7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Guru Nanak Eye Centre,New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of ophthalmology Guru Nanak Eye Centre New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Anjali K |
Maulana Azad Medical College |
Department of ophthalmology Guru Nanak Eye Centre New Delhi
New Delhi
DELHI |
9447864303
anjalikpayyanur7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with diabetes mellitus in the age group of 18-50 years
2.Patient having best corrected visual acuity of atleast 6/60 |
|
| ExclusionCriteria |
| Details |
1.Patients having other ocular disease like glaucoma,media opacity,optic nerve disorder,coexisting retinal diseases especially those which affect macular perfusion(eg.uveitis,vasculitis,vascular occlusion,hypertensive retinopathy)
2.Patients with high refractive error,poorly dilating pupils,ocular trauma or any surgery otherthan uneventful cataract surgery
3.Patient with previous history of stroke,transient ischemic attack or history of intake of antimigraine drugs
4.patients on any treatmnet including lasers or intravitreal antivegf injection for diabetic retinopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ocular blood flow(Peak systolic velocity,end diastolic velocity,resistivity index of ophthalmic artery,central retinal artery,post ciliary arteries) in diabetic retinopathy patients |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optical coherence tomography angiography parameters(Foveal avascular zone,vessel density,radial peripapillary capillary plexus |
4 weeks |
| Posterior segment Optical coherence Tomography parameters(Central foveal thickness,subfoveal thickness |
4 weeks |
| Relation between ocular blood flow parameters and optical coherence tomography angiography parameters |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
07/10/2024 |
| 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 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
|
A TOTAL OF 52 PATIENTS OF AGE BETWEEN 18-50 YEARS HAVING MODERATE-SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY ENROLLED IN THE STUDY.A THOROUGH HISTORY TAKING AND OCULAR EXAMINATION WILL BE PERFORMED.COLOUR DOPPLER IMAGING (PEAK SYSTOLIC VELOCITY,END DIASTOLIC VELOCITY,RESITIVITY INDEX OF OPHTHALMIC ARTERY,CENTRAL RETINAL ARTERY AND POST CILIARY ARERY) AND OCT AND OCTA PARAMETERS RECORDED AND ASSESSED. |