Department of Ophthalmology, Gangnam Severance Hospital
Seoul, 146-92, South Korea
Completed
NCT Number: NCT01866579
Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography
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.
Completed
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Notify MeKey information
Conditions
Age range
20 year–70 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Primary lung tuberculosis who has not previously treated
- Age more than 19 years and less than 70 years old
Exclusion criteria
- spherical equivalent more than +6.00 diopter or less than -6.00 diopter by autorefraction
- Closed angel or intraocular pressure more than 21 mmHg
- Best corrected visual acuity less than 0.5 with severe cataract
- Retinal disorder include branch retinal vein occlusion, diabetic macular edema, wet-type age-related macular degeneration
- Age less than 20 years or older than 70 years old
- Any intraocular surgery less than 3 months
- Intellectual problems or illiterate whom could not obtained informed consent
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Yonsei University
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- May 31, 2013
- Registry last updated
- May 20, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.