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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01866579
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):
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.

Condition or disease
Primary Lung Tuberculosis

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ethambutol

ethambutol optic neuropathy

Primary Outcome Measures :
  1. Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who diagnosed with primary lung tuberculosis

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01866579

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Korea, Republic of
Department of Ophthalmology, Gangnam Severance Hospital
Seoul, Korea, Republic of, 146-92
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University Identifier: NCT01866579    
Other Study ID Numbers: 3-2013-0041
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Keywords provided by Yonsei University:
Retinal Nerve Fiber Layer Thickness, Optical Coherence Tomography, Ethambutol optic neuropathy
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections