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Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy

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ClinicalTrials.gov Identifier: NCT00432393
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in patients with recent onset NAION (less than 6 weeks duration).

Patients and Methods: In this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.


Condition or disease Intervention/treatment Phase
Nonarteritic Anterior Ischemic Optic Neuropathy Drug: levodopa-carbidopa Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy
Study Start Date : June 2002
Estimated Study Completion Date : April 2003


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • age greater than 50 years old
  • first ophthalmic examination within 6 weeks after onset of disease
  • presence of optic disc swelling followed by optic atrophy within 6 weeks
  • altitudinal, central or generalized visual field defect
  • normal ESR

Exclusion Criteria:

  • confirmed giant cell arteritis
  • history of any ocular surgeries
  • optic neuropathy due to acute bleeding
  • advanced diabetic retinopathy
  • uncontrolled glaucoma
  • any ocular disorders that cause visual acuity reduction rather than NAION
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00432393


Locations
Iran, Islamic Republic of
Ophthalmic research center
Tehran, Iran, Islamic Republic of, 1666694516
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Mohammad Pakravan, MD Shahid Beheshti University of Medical Sciences
More Information

ClinicalTrials.gov Identifier: NCT00432393     History of Changes
Other Study ID Numbers: 8125
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: February 2007

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists