Primary Lung Tuberculosis Clinical Trial
| Verified date | May 2014 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Ophthalmology, Gangnam Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography | 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. | Early Retinal Nerve Fiber Layer change of initial before anti-tuberculosis treatment, 4 months after anti-tuberculosis treatment, 6 months after anti-tuberculosis treatmen | No |