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

Primary Purpose

Nonarteritic Anterior Ischemic Optic Neuropathy

Status

Completed

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

levodopa-carbidopa

About this trial

This is an interventional treatment trial for Nonarteritic Anterior Ischemic Optic Neuropathy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Ophthalmic research center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00432393

First Posted

February 6, 2007

Last Updated

October 17, 2008

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00432393

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonarteritic Anterior Ischemic Optic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

levodopa-carbidopa

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Pakravan, MD

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic research center

City

Tehran

ZIP/Postal Code

1666694516

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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