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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00432393
First received: February 6, 2007
Last updated: October 17, 2008
Last verified: February 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Medical University:

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432393

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

No publications provided

ClinicalTrials.gov Identifier: NCT00432393     History of Changes
Other Study ID Numbers: 8125
Study First Received: February 6, 2007
Last Updated: October 17, 2008
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014