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

May 19, 2014 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 146-92
        • Department of Ophthalmology, Gangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients who diagnosed with primary lung tuberculosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ethambutol optic neuropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Early Retinal Nerve Fiber Layer change of initial before anti-tuberculosis treatment, 4 months after anti-tuberculosis treatment, 6 months after anti-tuberculosis treatmen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2013-0041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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