Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.

Asociación para Evitar la Ceguera en México18 enrolled

Overview

The goal of this double-blind prospective randomized clinical trial is to determine if the effect of intravenous erythropoietin is superior to the effect of intravenous methylprednisolone in cases of toxic optic neuropathy 4 weeks after therapeutic intervention. The main question it aims to answer: • Is there a difference in the visual recovery of toxic optic neuropathies treated with intravenous methylprednisolone in comparison with those treated with intravenous erythropoietin?

A double-blind prospective randomized clinical trial of treatment for toxic optic neuropathies comparing visual outcome of patients treated by standard treatment (intravenous methylprednisolone) vs intravenous erythropoietin. Enrollment: 18. Randomized groups (2) 1. Standard treatment (intravenous methylprednisolone) 2. Intravenous erythropoietin Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Toxic Optic Neuropathy Treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Both genres. * Age between 18 and 75 years. * Clinical diagnosis of toxic optic neuropathy (afferent pupillary defect, acquired dyschromatopsia, visual loss and bilateral prechiasmatic field defect). * Exposure with a temporal relationship of less than two weeks to a known toxicant for the function of the optic nerve. * Up to 21 days from symptom onset. * Informed consent signature. Exclusion Criteria: * History of previous optic neuropathy. * History of additional ophthalmological or neurological pathology that has caused permanent visual loss. * History of previous treatment with intravenous methylprednisolone or some other experimental treatment since the onset of symptoms. * Poorly controlled diabetes mellitus. * Poorly controlled systemic arterial hypertension. * Hemoglobin \>16 mg/dL * Patients with a history of thromboembolic event. * Patients with a history of coronary heart disease, myocardial infarction or cerebral vascular event. * Pregnancy or lactation.

Outcomes

Primary Outcomes

Change from Baseline Visual Capacity

Best corrected visual acuity

Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit

Secondary Outcomes

Change from Baseline Color vision

Color vision as measured by Ishihara plates

Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit

Change from Baseline Visual field defect

Visual fields as measured by Goldmann perimetry

Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit

Change from Baseline Oct pRNFL (microns)

Nerve fiber thickness as measured by OCT

Time frame: Initial visit, 3-month visit

Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts