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Prospective study to evaluate incidence and indicators for early detection of ethambutol toxicity
  1. Sohini Mandal1,
  2. Rohit Saxena1,
  3. Rebika Dhiman1,
  4. Anant Mohan2,
  5. Srikanta Kumar Padhy1,
  6. Swati Phuljhele1,
  7. Pradeep Sharma1,
  8. Randeep Guleria2
  1. 1 Department of Ophthalmology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India
  2. 2 Department of Pulmonary Critical Care and Sleep Medicine, AIIMS, New Delhi, India
  1. Correspondence to Rohit Saxena, Professor of Ophthalmology, Strabismus and Neuro-ophthalmology Services, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India; rohitsaxena80{at}


Aims To evaluate incidence of toxic optic neuropathy in patients receiving ethambutol (EMB) for 6 months and to identify its early indicators.

Methods We included 50 patients on anti-tubercular therapy (ATT) including EMB (HRE regimen) based on total body weight for 6 months. Best-corrected visual acuity (ETDRS), colour vision (Ishihara pseudo-isochromatic plates), contrast sensitivity (Pelli-Robson chart), Humphrey visual field analysis (HVF 30-2 SITA FAST), pattern visual evoked response (VER) and spectral-domain optical coherence tomography (SDOCT) for ganglion cell inner plexiform layer (GCIPL) and retinal nerve fibre layer (RNFL) analysis were assessed at baseline and at 2, 4 and 6 months after starting ATT.

Results Mean age of the patients was 36.5±14.7 years with male:female ratio of 2.5:1. Mean daily dosage of EMB was 17.5±1.3 mg/kg/day. No significant change was observed in visual acuity, contrast sensitivity, color vision and mean or pattern SD on HVF at 6 months. Significant increase in VER latency of >2 SD (>125 ms) was observed in 46% eyes on follow-up indicating subclinical toxicity. Significant loss of mean RNFL (from 100.79±16.05 μm to 89.96±13.79 μm) and GCIPL thickness (from 83.1±5.60 μm to 79.85±6.45 μm) was observed at 6 months (p=0.001 for both). Patients with subclinical toxicity had significantly greater damage in temporal RNFL quadrant, supero-nasal and infero-nasal GCIPL sectors compared with others.

Conclusion The incidence of clinical EMB optic neuropathy was <2%, though subclinical damage in the form of increase in VER latency, and decrease in RNFL and GCIPL on OCT was seen in 46% eyes.

  • Electrophysiology
  • Drugs
  • Optic Nerve

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  • Contributors SM, RS—conception, data acquisition, data analysis, manuscript preparation, manuscript review. RD, SKP—manuscript preparation, manuscript review. AM—conception, manuscript review. SPA, PS, RD—critical review, manuscript preparation.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Obtained.

  • Ethics approval Institution review board of All India Institute of Medical Sciences, New Delhi, India and adhered to the tenets of the declaration of Helsinki. Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110 029. ID: IECPG-368/28.09.2017, RT-23/20.12.201.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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