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To see the effects of ethambutol, which is a drug for treatment of tuberculosis, on the ocular structure and function of patients

Effects of ethambutol on the ocular structure and function of patients receiving anti – tuberculous treatment - EMBON

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068652
Enrollment
110
Registered
2024-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A199- Miliary tuberculosis, unspecified Health Condition 2: A159- Respiratory tuberculosis unspecified Health Condition 3: A179- Tuberculosis of nervous system, unspecified Health Condition 4: A188- Tuberculosis of other specified organs

Interventions

Control Intervention1: 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-

Sponsors

Department of Ophthalmology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Visual acuity Best corrected visual acuity Visual fields Colour vision VEP OCT RNFL OCT MACULA Contrast sensitivityTimepoint: first visit at the start of TB treatment second visit at 2 months third visit at 4 months

Secondary

MeasureTime frame
Deterioration in ocular function or structure in terms of colour vision contrast sensitivity visual acuity visual fields VEP oct scansTimepoint: 2 months & 4 months

Countries

India

Contacts

Public ContactDr Suresh Kumar

Government Medical College & Hospital, Sector-32, Chandigarh

drsuresh.kumar.gupta@gmail.com9646121588

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026