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

NCT ID: NCT00432393

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nonarteritic Anterior Ischemic Optic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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levodopa-carbidopa

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Mohammad Pakravan, MD

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

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Ophthalmic research center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8125

Identifier Type: -

Identifier Source: org_study_id