| CTRI Number |
CTRI/2020/11/029052 [Registered on: 11/11/2020] Trial Registered Prospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of changes in retinal layers following retinal vein occlusion using a newer modality of testing-Optical Coherence Tomography Angiography. |
|
Scientific Title of Study
|
Optical Coherence Tomography Angiography microvascular findings in Retinal Vein Occlusion. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| New ID |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEENET JOSE EDASSERY |
| Designation |
DOCTOR(RESIDENT) |
| Affiliation |
SHRI KANCHI KAMAKOTI MEDICAL TRUST HOSPITAL. |
| Address |
DNB RESIDENT
SANKARA EYE HOSPITAL,
16-A SATHY ROAD,
SARAVANAMPATTY,COIMBATORE.
16-A,SATHY ROAD ,SARAVANAMPATTY,COIMBATORE
Coimbatore
TAMIL NADU
641035
India |
| Phone |
8547078981 |
| Fax |
|
| Email |
neenettt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrM PRABHUSHANKER |
| Designation |
CONSULTANT |
| Affiliation |
SHRI KANCHI KAMAKOTI MEDICAL TRUST HOSPITAL. |
| Address |
HEAD OF THE DEPARTMENT
(RETINA)
SANKARA EYE HOSPITAL,SATHY ROAD,SIVANANDAPURAM
COIMBATORE
16-A,SATHY ROAD ,SARAVANAMPATTY,COIMBATORE
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9443186568 |
| Fax |
|
| Email |
drprabhushanker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEENET JOSE EDASSERY |
| Designation |
DOCTOR(RESIDENT) |
| Affiliation |
SHRI KANCHI KAMAKOTI MEDICAL TRUST HOSPITAL. |
| Address |
DNB RESIDENT
SANKARA EYE HOSPITAL,
16-A SATHY ROAD,
SARAVANAMPATTY,COIMBATORE.
16-A,SATHY ROAD ,SARAVANAMPATTY,COIMBATORE
Coimbatore
TAMIL NADU
641035
India |
| Phone |
8547078981 |
| Fax |
|
| Email |
neenettt@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI KANCHI KAMAKOTI MEDICAL TRUST HOSPITAL |
|
|
Primary Sponsor
|
| Name |
NEENET JOSE EDASSERY |
| Address |
SANKARA EYE HOSPITAL,
16-A SATHY ROAD,
SIVANANDAPURAM,COIMBATORE |
| 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 |
| NEENET JOSE EDASSERY |
SHRI KANCHI KAMAKOTI MEDICAL TRUST HOSPIATL |
Department of vitreoretina,Room no:7,Sankara eye hospital,Sathy road,Sivanandapuram
Coimbatore
TAMIL NADU |
08547078981
neenettt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE - SANKARA EYE CARE INSTITUTIONS SANKARA EYE HOSPITAL 16 A, SATHY ROAD Sathy Road,sivanandapuram, COIMBATORE Coimbatore Tamil NaduECR/512/Inst/TN/2014/RR-20 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: H349||Unspecified retinal vascular occlusion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
|
|
| ExclusionCriteria |
| Details |
retinal artery occlusion
diabetic retinopathy
recent intravitreal injections
recent retinal surgeries
recent laser treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantification of changes of vascular density of retina. |
On the day of diagnosis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of central macular thickness,size of foveal avascular zone and correlating with visual acuity. |
On the day of the diagnosis |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
17/11/2020 |
| 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="2"
Months="6"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients diagnosed with retinal vein occlusion will be assessed in the study. Complete ophthalmologic examination and assessment using Optical Coherence Tomography Angiography will be done and the results obtained will be evaluated. |