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

Nonarteritic Anterior Ischemic Optic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432393
• Other study ID #: 8125
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2007
• Last updated: October 17, 2008
• Start date: June 2002
• Est. completion date: April 2003

Study information

• Verified date: February 2007
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2003
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Nonarteritic Anterior Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Drug:
• levodopa-carbidopa

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic research center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of,