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To assess the prevalence of Optic neuropathy due to the commonly used anti tubercular drug- Ethambutol and to study whether steroids have any role in treating it.

To assess the incidence of Ethambutol induced Optic neuropathy (EtON) and evaluate the role of high dose pulse methylprednisolone (IVMP)in these patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031606
Enrollment
50
Registered
2021-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: H463- Toxic optic neuropathy

Interventions

Intervention1: Standard Therapy with Methylprednisolone: Standard Therapy with Methylprednisolone ( IV 1 gm daily for 5 days) Control Intervention1: Standard Therapy with Placebo: Standard Therapy wit

Sponsors

Indian Council of Medical ResearchICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than13 years 2. Patients receiving Ethambutol for treatment of TB ( PULMONARY/ EXTRAPULMONARY){for analysing the community incidence of EtON}. 3. Patients on Ethambutol developing Optic Neuropathy{ For Intervention}

Exclusion criteria

Exclusion criteria: 1. Patients with secondary causes of visual loss 2. Patients with probable medical conditions with contraindication to steroids a. Activeinfection b. Sepsis c. Uncontrolled Diabetes Mellitus, Hypertension d. Any other contraindication to steroids 3. Pregnant or lactating women 4. Patients not consenting for the study

Design outcomes

Primary

MeasureTime frame
Improvement in the visual functionsTimepoint: Patients will be assessed after two weeks of pulse dose steroids traetment and will be followed up after one month and then after every two months

Secondary

MeasureTime frame
Safety of the interventionTimepoint: Immediate side effects will be noted at the time of administration of intravenous methylprednisolone.

Countries

India

Contacts

Public ContactVivek Lal

Post Graduate Institute of medical education and Research (PGIMER)

vivekl44@yahoo.com7087006691

Outcome results

None listed

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