| CTRI Number |
CTRI/2024/06/068652 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effects of ethambutol, which is a drug for treatment of tuberculosis, on the ocular structure and function of patients |
|
Scientific Title of Study
|
Effects of ethambutol on the ocular structure and function of patients receiving anti – tuberculous treatment |
| Trial Acronym |
EMBON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahima Kaushal |
| Designation |
PG-Junior Resident |
| Affiliation |
Government Medical College & Hospital, Sector-32, Chandigarh |
| Address |
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160020
India |
| Phone |
7837255884 |
| Fax |
|
| Email |
mahima.kaushal15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College & Hospital, Sector-32, Chandigarh |
| Address |
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160020
India |
| Phone |
9646121588 |
| Fax |
|
| Email |
drsuresh.kumar.gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Kumar |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College & Hospital, Sector-32, Chandigarh |
| Address |
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160020
India |
| Phone |
9646121588 |
| Fax |
|
| Email |
drsuresh.kumar.gupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital, Sector 32, Chandigarh
India
160020 |
|
|
Primary Sponsor
|
| Name |
Department of Ophthalmology |
| Address |
GMCH32 Sector 32 Chandigarh
India
160020 |
| 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 Mahima Kaushal |
Government Medical College and Hospital Sector32 Chandigarh |
Department of Ophthalmology, D Block Level 3, Government medical college and hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH |
7837255884
mahima.kaushal15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified, (2) ICD-10 Condition: A188||Tuberculosis of other specified organs, (3) ICD-10 Condition: A199||Miliary tuberculosis, unspecified, (4) ICD-10 Condition: A159||Respiratory tuberculosis unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral administration of Ethambutol 15-25 mg/kg/day for 6 months |
Ethambutol drug has been known to cause ocular toxicity which may be irreversible. The use of ethambutol in anti-tuberculous treatment for tuberculosis patients is a part of the daily fixed dose regimen. The study will evaluate ocular structure function of the patients before being started on ethambutol and compare with the status of ocular stucture and function at 2 months and 4 months while the patients are taking ethambutol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of Tuberculosis (Clinically or Microbiologically proven/ Sputum smear positive) from the age of 18 years and above – receiving daily regimen of ATT (2HRZE+4HRE regimen) |
|
| ExclusionCriteria |
| Details |
Category II, III, IV Tuberculosis patients
Moderate-to-severe Glaucoma
Hereditary Optic Neuropathy
Ischemic Optic Neuropathy
Traumatic Optic Neuropathy
HIV patients on Anti-Retroviral therapy
Ocular TB
Tubercular meningitis
Any systemic medical condition (e.g., cognitive impairment, Parkinson’s disease, Alzheimer’s disease, Multiple sclerosis and any other neurological or musculoskeletal disease) which might preclude the patient from giving reliable results on investigations |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity
Best corrected visual acuity
Visual fields
Colour vision
VEP
OCT RNFL
OCT MACULA
Contrast sensitivity |
first visit at the start of TB treatment
second visit at 2 months
third visit at 4 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Deterioration in ocular function or structure in terms of colour vision
contrast sensitivity
visual acuity
visual fields
VEP
oct scans |
2 months & 4 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/06/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
the patients will get done an array
of non-invasive investigations on initiation of anti-tuberculosis treatment and on follow
ups, to detect changes in their ocular structure and function, which we can
reasonably anticipate keeping the increased dose and extended regimen of anti-tuberculous treatment. |