| CTRI Number |
CTRI/2025/10/095834 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Causes and Treatment Results of Eye Vein Blockage |
|
Scientific Title of Study
|
Analysis of risk factors and outcome of Intravitreal anti-VEGF in 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 |
SUTHIKSHA V |
| Designation |
Post DO DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
16A Sathy Road near Prozone Mall Saravanampatti Siranandha Puram Coimbatore Tamil Nadu 641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9994114502 |
| Fax |
|
| Email |
suthikshavijay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha G |
| Designation |
Senior Consultant |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
16A Sathy Road near Prozone Mall Saravanampatti Siranandha Puram Coimbatore Tamil Nadu 641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9442016032 |
| Fax |
|
| Email |
geetha@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
SUTHIKSHA V |
| Designation |
Post DO DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
16A Sathy Road near Prozone Mall Saravanampatti Siranandha Puram Coimbatore Tamil Nadu 641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9994114502 |
| Fax |
|
| Email |
suthikshavijay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Coimbatore |
|
|
Primary Sponsor
|
| Name |
SUTHIKSHA V |
| Address |
16-A, Sathy Road, near Prozone Mall, Saravanampatti, Siranandha Puram, Coimbatore,Tamil Nadu 641035 |
| 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 |
| SUTHIKSHA V |
Sankara Eye Hospital |
16A Sathy Road near Prozone Mall Saravanampatti Siranandha Puram Coimbatore Tamil Nadu 641035
Coimbatore
TAMIL NADU |
9994114502
suthikshavijay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Intervention |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Treatment naive cases of RVO
Presence of clinically significant macular oedema secondary to RVO confirmed by OCT
BCVA of 6 by 12 to 6 by 60 in the study eye
CMT or CFT above 300 micrometer
|
|
| ExclusionCriteria |
| Details |
Previous treatment for RVO in the study eye
Retinal diseases other than RVO
Significant media opacities
Recent history of thromboembolic events
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of biochemical markers in patients newly diagnosed with Retinal Vein Occlusion (RVO) |
Baseline first visit, Post injection 1week, 1month, 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Therapeutic response in relation to pre-treatment biomarker influence |
Baseline first visit, Post injection 1week,1month, 3months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/10/2025 |
| 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="0"
Months="9"
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 prospective observational study aims to analyze the role of biochemical abnormalities—Vitamin B12 deficiency, hyperhomocysteinemia, and Protein C/S deficiencies—in the development and prognosis of Retinal Vein Occlusion (RVO). Forty newly diagnosed RVO patients with macular edema will undergo biochemical testing, ocular examination, and OCT imaging, followed by intravitreal anti-VEGF treatment. Visual acuity and macular thickness will be monitored over a period of 3 months. The study seeks to determine whether these biochemical abnormalities increase RVO risk and influence response to anti-VEGF therapy. |