Optic Neuritis Treatment and Long-Term Follow-Up Study
Data Collection
Autoimmune Diseases+8
+ Cranial Nerve Diseases
+ Demyelinating Diseases
Treatment Study
Summary
Study start date: July 1, 1988
Actual date on which the first participant was enrolled.Optic neuritis is a condition that affects young adults, especially women, causing inflammation in the optic nerve. It's the second most common acquired optic nerve disorder in people under 50. While visual recovery is generally good, it's rarely complete, and most patients continue to show signs of optic nerve damage. Before the Optic Neuritis Treatment Trial (ONTT), there were no established guidelines for treating optic neuritis. This study, known as the Longitudinal Optic Neuritis Study (LONS), aims to provide a clearer understanding of the condition and its treatment, potentially improving care for those affected. In this study, participants are assigned to one of three treatment groups at 15 clinical centers in the United States. The groups receive either oral prednisone for 14 days, intravenous methylprednisolone for 3 days followed by oral prednisone for 11 days, or a placebo for 14 days. The recovery and long-term visual outcomes are evaluated through measures of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven follow-up visits in the first 6 months, and then yearly. A standardized neurological examination is also conducted at baseline, after 6 months, and then annually.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 46 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
California Pacific Medical Center
San Francisco, United StatesGeorgetown University
Washington D.C., United StatesUniversity of Florida
Gainesville, United States