| CTRI Number |
CTRI/2024/07/070115 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of visual recovery after Optic Neuritis(swelling of nerve of the eye) in a hospital in Coastal Karnataka
|
|
Scientific Title of Study
|
Evaluation of Outcome of Optic Neuritis (ON) Cases presenting to
Department of Ophthalmology in a Tertiary Care Hospital in Coastal Karnataka
|
| 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 Soumya S |
| Designation |
Assisant Professor |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Madhav Nagar, Manipal-576104 ​
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
soumya.nair@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Bajoria |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9615289959 |
| Fax |
|
| Email |
prachi.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Bajoria |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9615289959 |
| Fax |
|
| Email |
prachi.kmcmpl2022@learner.manipal.edu |
|
Source of Monetary or Material Support
Modification(s)
|
| Kasturba Medical College,Madhav Nagar, Manipal,Karnataka,India-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Madhav Nagar, Manipal-576104 |
| Type of Sponsor |
Private 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 Prachi Bajoria |
Kasturba Medical College Manipal |
​Department of Ophthalmology, Kasturba Hospital, Madhav Nagar, Manipal-576104 ​
Udupi
KARNATAKA |
9615289959
prachi.kmcmpl2022@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Students Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H461||Retrobulbar neuritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-All patients who have been evaluated for optic neuritis in Department of Ophthalmology
-In the study period i.e. June 2024 to May 2025
|
|
| ExclusionCriteria |
| Details |
-Patients diagnosed with non-inflammatory optic neuropathy like optic nerve compression,
malignant infiltration, chronic toxic optic neuropathy, traumatic optic neuropathy, nutritional
optic neuropathy, Leber’s hereditary optic neuropathy, drug induced optic neuropathy,
ischaemic optic neuropat
-Diagnosed to have optic neuritis outside the period of study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Correlation of outcome to different aetiologies |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Description of the demographic pattern of optic neuritis
• Characterisation of the aetiology of optic neuritis
• Description of the clinical characteristics of optic neuritis |
6 months |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
15/07/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
While optic neuritis is frequently associated with multiple sclerosis (MS), the causes of optic neuritis are protean. As a result, the prognosis of optic neuritis may vary depending upon the aetiology, the duration and severity of vision loss. Optimal care of patients with optic neuritis therefore depends on rapid recognition and appropriate diagnostic studies. Very few studies have described the outcome of optic neuritis and correlated that to the aetiology. With this study, we aim to determine the demographic patterns and aetiology of optic neuritis and correlate the outcome to the aetiology of the disease at our centre, if any. The results may help ophthalmologists have a high index of suspicion, leading to early institution of effective therapies and thus better visual outcome. |