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Longitudinal Optic Neuritis Study (LONS)

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ClinicalTrials.gov Identifier: NCT00000147
Recruitment Status : Unknown
Verified October 1999 by National Eye Institute (NEI).
Recruitment status was:  Active, not recruiting
First Posted : September 24, 1999
Last Update Posted : May 29, 2006
Information provided by:
National Eye Institute (NEI)

Brief Summary:

To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.

To determine the natural history of vision in patients who suffer optic neuritis.

To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Optic Neuritis Drug: Methylprednisolone Drug: Prednisone Not Applicable

Detailed Description:

Optic neuritis is an inflammatory disease of the optic nerve that typically affects young adults. Women are affected more often than men. It is second only to glaucoma as the most common acquired optic nerve disorder in persons younger than age 50.

In this disorder, closely linked to multiple sclerosis, prognosis for visual recovery is generally good. However, return of visual function is almost never complete. After resolution of optic neuritis, virtually all patients show some signs of optic nerve damage, and most are symptomatic. Even when a patient's acuity recovers to 20/20, abnormalities frequently remain in other measures such as contrast sensitivity, color vision, and visual field.

Prior to the Optic Neuritis Treatment Trial (ONTT), well-established guidelines for treating optic neuritis did not exist. Although corticosteroids had been used to treat this disease, studies to demonstrate their effectiveness had not been satisfactory. Some experts advocated treatment with oral prednisone while others recommended no treatment. Anecdotal reports suggested that high-dose intravenous corticosteroids might be effective.

The association between optic neuritis and multiple sclerosis is well established. Optic neuritis may be the first manifestation of multiple sclerosis, or it may occur later in its course. A strong case can be made for "isolated" optic neuritis being a forme fruste of multiple sclerosis, based on similarities between the two in such epidemiologic factors as gender, age, geographic distributions, cerebrospinal fluid changes, histocompatibility data, magnetic resonance imaging (MRI) changes, and family history. The magnitude of the risk of multiple sclerosis after optic neuritis is uncertain. Previous studies have reported very disparate results, with the risk being reported to be as low as 13 percent and as high as 88 percent. The importance of risk factors such as age, gender, and MRI changes in predicting which patients with optic neuritis are most likely to develop multiple sclerosis also is unclear.

The treatment phase of the study was called the Optic Neuritis Treatment Trial (ONTT), whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study (LONS). The study is being conducted at 15 clinical centers in the United States. Resource centers include a data coordinating center and a visual field reading center.

Patients were randomized to one of the three following treatment groups at 15 clinical centers:

  • Oral prednisone (1 mg/kg/day) for 14 days
  • Intravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral prednisone (1 mg/kg/day) for 11 days
  • Oral placebo for 14 days.

Each regimen was followed by a short oral taper. The oral prednisone and placebo groups were double masked, whereas the intravenous methylprednisolone group was single masked.

Baseline testing included blood tests to evaluate for syphilis and systemic lupus erythematosus, a chest x-ray to evaluate for sarcoidosis, and a brain MRI scan to evaluate for changes suggestive of multiple sclerosis.

The rate of visual recovery and the long-term visual outcome were both assessed by measures of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven followup visits during the first 6 months, and then yearly. A standardized neurologic examination with an assessment of multiple sclerosis status was made at baseline, after 6 months, and then yearly.

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Study Type : Interventional  (Clinical Trial)
Masking: Single
Primary Purpose: Treatment
Study Start Date : July 1988

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

The major eligibility criteria for enrollment into the ONTT included the following:

Age range of 18 to 46 years

Acute unilateral optic neuritis with visual symptoms for 8 days or less

A relative afferent pupillary defect and a visual field defect in the affected eye

No previous episodes of optic neuritis in the affected eye

No previous corticosteroid treatment for optic neuritis or multiple sclerosis

No systemic disease other than multiple sclerosis that might be the cause of the optic neuritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000147

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United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States
United States, California
California Pacific Medical Center
San Francisco, California, United States
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States
United States, Florida
University of Florida
Gainesville, Florida, United States
United States, Illinois
University of Illinois
Chicago, Illinois, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
United States, New York
New York University
New York, New York, United States
United States, North Carolina
Duke University
Durham, North Carolina, United States
United States, Oregon
Devers Eye Institute
Portland, Oregon, United States
United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
United States, Washington
Swedish Medical Center
Seattle, Washington, United States
Sponsors and Collaborators
National Eye Institute (NEI)
Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210

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ClinicalTrials.gov Identifier: NCT00000147    
Other Study ID Numbers: NEI-48
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: May 29, 2006
Last Verified: October 1999
Additional relevant MeSH terms:
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Multiple Sclerosis
Optic Neuritis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents