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A study to identify clinical and inborn risk factors for development of vision impairment in patients on Ethambuol, an antituberculosis drug

A pharmacogenomics study to identify genetic risk factors for development of Ethambutol optic neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/08/045044
Enrollment
500
Registered
2022-08-30
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: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: nil: nil

Sponsors

Duke NUS Program Grant Award
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients newly started on anti tuberculosis treatment will be included in the study. 2)Each patient will be followed up until the duration of treatment is completed depending on the treatment regime. 3)Once follow up is completed for all recruited patients, EON(Ethambutol optic neuropathy) will be defined by visual acuity assessment to test the inability of the patient to see clearly in dim light post treatment. 4)Patients who develop EON during the study period will be classified as cases and treated patients who did not develop EON will be classified as controls.

Exclusion criteria

Exclusion criteria: Patients with previous optic neuropathy of other causes and retinal pathology causing vision impairment will be excluded

Design outcomes

Primary

MeasureTime frame
Biomarker Discovery and Replication - To uncover the genetic susceptibility factors that predisposed treated patients to the development of EON.Timepoint: 1 month, 3 months, 6 months

Secondary

MeasureTime frame
1)To study the clinical profile of patients who develop EON. 2)Biomarker Discovery and Replication - To uncover the genetic susceptibility factors that predisposed treated patients to the development of EON.Timepoint: 1 month, 3 months, 6 months

Countries

India

Contacts

Public ContactDrVirna M Shah

Aravind Eye Hospital

virna@aravind.org9894772036

Outcome results

None listed

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