Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography

Completed

• Conditions: Primary Lung Tuberculosis

• Registration Number: NCT01866579
• Lead Sponsor: Yonsei University

Brief Summary

Ethambutol is widely used as first-line drug, but has serious side effect of optic neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1\~2%, there was considerable screening efforts and medical cost is increasing. However, there is no effective treatment of ethambutol optic neuropathy or no definite preventable measure. Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is emerging, more toxic secondary drug is used in the long-term.

It is known that retinal nerve fiber layer is increased early stage in ethambutol optic neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by optical coherence tomography in longitudinal manner.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Primary lung tuberculosis who has not previously treated
2. Age more than 19 years and less than 70 years old

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Exclusion Criteria

1. spherical equivalent more than +6.00 diopter or less than -6.00 diopter by autorefraction
2. Closed angel or intraocular pressure more than 21 mmHg
3. Best corrected visual acuity less than 0.5 with severe cataract
4. Retinal disorder include branch retinal vein occlusion, diabetic macular edema, wet-type age-related macular degeneration
5. Age less than 20 years or older than 70 years old
6. Any intraocular surgery less than 3 months
7. Intellectual problems or illiterate whom could not obtained informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography	Early Retinal Nerve Fiber Layer change of initial before anti-tuberculosis treatment, 4 months after anti-tuberculosis treatment, 6 months after anti-tuberculosis treatmen	Retinal Nerve Fiber Layer is axon of the retinal ganglion cell. It can be measured by optical coherence tomography. It is non-invasive and good reproducibility method to measure retinal nerve fiber layer in vivo.

Trial Locations

Locations (1)

Department of Ophthalmology, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of