| CTRI Number |
CTRI/2024/09/073421 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Platelet Aggregation Response To Factors in Patients Of occlusive Retinal Vein Disorders |
|
Scientific Title of Study
|
Evaluation of Platelet Aggregation response to Epinephrine, Collagen and Ristocetin in patients 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 Punita Kumari Sodhi |
| Designation |
Director Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of ophthalmology Maulana Azad Medical College And
Associated Guru nanak Eye Centre New Delhi Guru Nanak Eye
Centre New Delhi
New Delhi
DELHI
110002
India
New Delhi
DELHI
110002
India |
| Phone |
9968604414 |
| Fax |
|
| Email |
sodhipunita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of ophthalmology Maulana Azad Medical College And
Associated Guru nanak Eye Centre New Delhi Guru Nanak Eye
Centre New Delhi
New Delhi
DELHI
110002
India
New Delhi
DELHI
110002
India |
| Phone |
8059484067 |
| Fax |
|
| Email |
alokrohilla99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of ophthalmology Maulana Azad Medical College And
Associated Guru nanak Eye Centre New Delhi Guru Nanak Eye
Centre New Delhi
New Delhi
DELHI
110002
India
New Delhi
DELHI
110002
India |
| Phone |
8059484067 |
| Fax |
|
| Email |
alokrohilla99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Guru Nanak Eye Centre, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
Department Of Ophthalmology, Maulana Azad Medical College, Guru Nanak Eye Centre, new delhi 110002, 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 Alok Kumar |
Maulana Azad Medical College |
Department Of
Ophthalmology Guru
Nanak Eye Centre
New Delhi
DELHI
New Delhi
DELHI |
8059484067
alokrohilla99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of branch retinal vein occlusion, in the age range of 45-65 years
2. Patients having normal platelet count, prothrombin time and activated partial thromboplastin time
|
|
| ExclusionCriteria |
| Details |
1. Patients having other significant ocular diseases like glaucoma, media opacity, optic nerve disorders, high refractive errors, other significant co-existing retinal diseases especially those which affect macular perfusion (e.g. diabetic retinopathy, uveitis and vasculitis)
2. Patients having best corrected visual acuity lesser than 6/60
3. Patients on any anti-platelet-aggregating drugs, anticoagulants or non-steroidal anti-inflammatory drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Platelet aggregation response to agonists including epinephrine, collagen and ristocetin in patients of branch retinal vein occlusion |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Optical coherence tomography angiography parameters (Foveal Avascular Zone, vessel density) &
2. Posterior segment Optical Coherence Tomography parameters (Central foveal thickness & sub- foveal choroidal thickness)
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/09/2024 |
| 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 30 PATIENTS OF AGE BETWEEN 45 TO 65 YEARS HAVING BRANCHED RETINAL VEIN OCCLUSION WILL BE ENROLLED IN THIS STUDY . A THOROUGH HISTORY TAKING AND OCCULAR EXAMINATION WILL BE PERFORMED . PLATLET AGGREGATION RESPONSE OF PATIENTS BLOOD TO AGONISTS INCLUDING COLLAGEN , RISTOCETIN AND EPINEPHRINE WILL BE OBSERVED AND OCT AND OCTA PARAMETERS WILL BE RECORDED . |