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

October 17, 2008 updated by: Shahid Beheshti University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Pakravan, MD, Shahid Beheshti University of Medical Sciences

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

June 1, 2002

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (Estimate)

February 7, 2007

Study Record Updates

Last Update Posted (Estimate)

October 20, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8125

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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