| CTRI Number |
CTRI/2024/08/071831 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To establish whether platelet morphology or functions are altered in patients of Retinal Vein Occlusion |
|
Scientific Title of Study
|
Estimation of Generation of Prothrombotic Phenotype in cases of Retinal Vein Occlusion |
| 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 Deepak Mishra |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute Of Ophthalmology,Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Room no 504, 5th floor,RIO, Department of Ophthalmology, IMS, BHU, Varanasi(221005)
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415360338 |
| Fax |
|
| Email |
drdmishra12@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Regional Institute of Medical Sciences
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh
221005
INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7631723764 |
| Fax |
|
| Email |
dipti321bobby@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipti |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Regional Institute of Medical Sciences
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh
221005
INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7631723764 |
| Fax |
|
| Email |
dipti321bobby@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Ophthalmology, Regional Institute of Ophthalmology, Institute of Medical Sciences ,Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Regional Institute of Ophthalmology, Institute of Medical Sciences ,Banaras Hindu University
221005
Varanasi
Uttar Pradesh
India |
| 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 Dipti |
Institute of Medical Sciences, Banaras Hindu University |
Department of Bichemistry ,Institute of Medical Sciences ,Banaras Hindu University
Regional Institute of Ophthalmology ,Institute Of Medical Sciences, Banaras Hindu University
221005
Varanasi
Uttar Pradesh
India
Varanasi
UTTAR PRADESH |
7631723764
dipti321bobby@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H348||Other retinal vascular occlusions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flowcytometry |
Flowcytmetry to assess platelets- neutrophils complex in blood of retinal vein occlusion patients compared to healthy matched controls |
| Comparator Agent |
Thromboelastography
|
Thromboelastography at time of presentation in blood of retinal vein occlusion patients compared to healthy age matched controls
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All cases of Retinal Vein Occlusion attending the outpatient department of RIO, IMS, BHU .
Cases giving written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Acute inflammatory state
Patients on anti platelet and anti-coagulant drugs
Patients with glaucoma or any optic nerve disorder
Patients suffering from major systemic diseases like diabetes mellitus, cardiovascular diseases, anemia, cancer
Pregnant and lactating women
Patients with other ocular disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Thromboelastography
Flowcytometry for assessing platelet neutrophil aggregates circulation
OCT macula |
Day 0 to Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Best corrected visual acuity
2.Slit Lamp Biomicroscopy
3.Oct macula |
DAY 0
WEEK 1
WEEK 12 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
15/08/2024 |
| 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
|
The aim of the study is to evaluate altered clotting dynamics in cases of Retinal Vein Occlusion using Thromboelastography, which may be useful tool to elucidate its pathophysiology. Further we also try to establish the consequences of platelet neutrophil interactions resulting in increased thrombotic events. |