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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432393
First Posted: February 7, 2007
Last Update Posted: October 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose

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 Intervention Phase
Nonarteritic Anterior Ischemic Optic Neuropathy Drug: levodopa-carbidopa Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Study Start Date: June 2002
Estimated Study Completion Date: April 2003
  Eligibility

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 Submitted: February 6, 2007
First Posted: February 7, 2007
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