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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01866579

Enrollment

Registered

2013-05-31

Start date

2013-05-31

Completion date

2014-05-31

Last updated

2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Lung Tuberculosis

Keywords

Retinal Nerve Fiber Layer Thickness, Optical Coherence Tomography, Ethambutol optic neuropathy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results