| CTRI Number |
CTRI/2020/05/025129 [Registered on: 12/05/2020] Trial Registered Prospectively |
| Last Modified On: |
07/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
clinical outcomes of patients with injury to the optic nerve - A prospective study in an institute |
|
Scientific Title of Study
|
Treatment Outcomes of Patients with Traumatic Optic Neuropathy - A prospective study in a tertiary care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Antony Raj James |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medicine Education and research |
| Address |
Department of ENT,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500181901 |
| Fax |
|
| Email |
antonyrajjames@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sivaraman G |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Institue of postgraduate medicine education and research |
| Address |
Department of ENT,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442355292 |
| Fax |
|
| Email |
gsivram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivaraman G |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Institue of postgraduate medicine education and research |
| Address |
Department of ENT,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442355292 |
| Fax |
|
| Email |
gsivram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ENT, JIPMER |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER
Pondicherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Antony Raj James |
JIPMER |
Department of ENT
Pondicherry
Pondicherry
PONDICHERRY |
9500181901
antonyrajjames@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institiute Ethics Committee, JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H470||Disorders of optic nerve, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed cases of traumatic optic neuropathy willing to give consent |
|
| ExclusionCriteria |
| Details |
1.open globe injury with Traumatic optic neuropathy
2.Cortical blindness
3.Complete avulsion of optic nerve
4. Polytrauma patient
5.Head injury patient |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Return of vision after medical or surgical management of traumatic optic neuropathy,at the time od admission, at the end of intervention, at the end of first month, second month and third month |
at admission, after intervention, at the time of first, second and third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Color vision
2.Visual field charting
3.Afferent pupillary defect
4.dilated fundus examination
immediately after procedure and at the end of first month, second month, third month |
3 years |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/05/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective longitudinal study, In patients present with traumatic optic neuropathy at the time of presentation a CT scan 1mm cuts will be taken to assess the presence of impingement. Once impingement is identified patient will be managed surgically and if impingement is absent the patient willl receive medical treatment( high dose prednisolne as per institute guidelines and their visions will be checked at the time of admission, immediately after treatment , at the end of first,second and third month |