Ischemic Optic Neuropathy Decompression Trial Followup (IONDT Followup)

May 25, 2006 updated by: National Eye Institute (NEI)
To follow all patients enrolled in the original Ischemic Optic Neuropathy Decompression Trial (IONDT) to determine (1) the incidence of non-arteritic ischemic optic neuropathy (NAION) in the second eye, (2) changes in visual acuity over time in both the study and second eye, and (3) other aspects of the natural history of NAION.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

NAION is the most common cause of acute optic nerve disease in the elderly, causing permanent and severe visual loss. No proven treatment currently exists to reverse or arrest this loss. There is no accepted method for the prevention or reduction of the likelihood of second eye involvement. NAION strikes both eyes in as many as 40 percent of affected patients (Beri et al. 1987), with a 2-year risk of about 25 percent (Steven Feldon, personal communication to SEK).

IONDT compared optic nerve decompression surgery (ONDS), which was becoming a widely used treatment for NAION, with careful followup alone, in patients with newly diagnosed NAION. The rationale for the surgery was that NAION was caused by impaired blood flow to the optic nerve and that decompression surgery would restore vision by alleviating pressure surrounding the nerve. Because ONDS was fast becoming the standard of care, evaluation of the safety and efficacy of the procedure was tested in the context of a randomized clinical trial.

Within 2 years of the start of the IONDT, the Data and Safety Monitoring Committee recommended cessation of the clinical trial recruitment. The National Institutes of Health issued a clinical alert to 25,000 ophthalmologists and neurologists describing the study findings that surgery was no better than careful followup and may be harmful (IONDT 1995). It was recommended that ONDS not be used in cases of NAION. Thus, the IONDT findings not only have led to a costly and ineffective surgery to be abandoned as a treatment for NAION, but also have left practitioners with a dearth of treatment choices.

The IONDT is the first multicenter, prospective study of newly diagnosed patients with NAION. The baseline history and examination, which took place within 14 days of the onset of symptoms, used standardized methods and diagnostic criteria to collect data on all factors possibly relating to the etiology of NAION. In reports from previous studies that present data on both initial and final visual acuities, no data are available regarding change in visual acuity over time for individual patients. Where data are available on final visual acuity, reported rates of improvement are low, ranging from 0 percent to 33 percent for untreated eyes. The IONDT found, however, an improvement of three or more lines in 42.7 percent of patients who received careful followup.

NAION in both eyes has been reported in as few as 10.5 percent and as many as 73 percent of patients. In a study of bilateral NAION where all patients were prospectively logged, Beri et al. reported that 17.5 percent of patients developed bilateral disease at 1 year of followup and 34.5 percent developed it at 5 years. However, Beck et al., using a life table analysis on the same cohort reported by Beri et al., estimated the risk of bilateral NAION to be 12 percent within 2 years and 19 percent within 5 years. The IONDT has so far similarly reported a 12 percent (25/216) incidence of bilateral NAION in its randomized patients. The incidence in the nonrandomized group, 91 percent of whom had visual acuity better than 20/64, is much lower at 4 percent (5/136).

Thus, continued followup of the IONDT cohort is critically important to ascertain a clear picture of the natural history of NAION in terms of involvement of the second eye and long-term vision. Data obtained will be critical in understanding the etiology of the disease and in generating hypotheses for testing further treatments for the disease.

The IONDT Followup Study will continue to monitor vision and other health outcomes in patients originally enrolled in the IONDT, whether randomized to one of the two treatment groups or whether followed as part of the natural history cohort. All IONDT patients were diagnosed with NAION within 14 days of onset of symptoms, have had a minimum of 2 years of continuous followup, and will be followed for an additional 4 years in the Followup Study. Patients will have annual visits at the original IONDT Clinical Center or, if necessary, with a surrogate provider. If NAION occurs in the second eye, the patient will be asked to visit the clinic for a special visit. The Coordinating Center will telephone the patients on a quarterly basis, between annual visits. Outcomes that will be examined include:

  • incidence of NAION in the second eye,
  • medical or ocular events surrounding the occurrence of NAION,
  • visual acuity (measured using the New York Lighthouse charts).

In the event of an NAION event in the second eye, the patient's visual field will be tested by using the Humphrey Perimeter.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • Doheny Eye Institute, University of Southern California
      • Los Angeles, California, United States
        • Jules Stein Eye Institute
      • San Francisco, California, United States
        • Department of Ophthalmology, University of California, San Francisco
    • Florida
      • Gainesville, Florida, United States
        • Department of Ophthalmology, University of Florida
    • Georgia
      • Atlanta, Georgia, United States
        • Emory Eye Center, Emory University
    • Illinois
      • Chicago, Illinois, United States
        • Department of Ophthalmology, University of Illinois
    • Kentucky
      • Lexington, Kentucky, United States
        • Department of Ophthalmology, University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland
    • Michigan
      • Ann Arbor, Michigan, United States
        • W.K. Kellogg Eye Center, University of Michigan
      • East Lansing, Michigan, United States
        • Department of Ophthalmology, Michigan State University
      • Royal Oak, Michigan, United States
        • William Beaumont Eye Institute, William Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States
        • Mason Institute of Ophthalmology, University of Missouri - Columbia
      • St. Louis, Missouri, United States
        • St. Louis University, Anheuser-Busch Eye Institute
    • New York
      • Syracuse, New York, United States
        • SUNY Health Science Center, Department of Neurology
    • North Carolina
      • Charlotte, North Carolina, United States
        • Carolinas Medical Center
    • Ohio
      • Cleveland, Ohio, United States
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Allegheny General Hospital
    • South Carolina
      • Columbia, South Carolina, United States
        • University of South Carolina, Department of Ophthalmology
    • Texas
      • Houston, Texas, United States
        • University of Texas
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah, Department of Ophthalmology
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia, Department of Ophthalmology
      • Richmond, Virginia, United States
        • Medical College of Virginia, Department of Neurology
    • West Virginia
      • Morgantown, West Virginia, United States
        • West Virginia University, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

All living patients from the 420 patients originally enrolled in the IONDT have been asked to participate in the IONDT Followup Study. No new patients are being recruited.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1994

Study Registration Dates

First Submitted

September 23, 1999

First Submitted That Met QC Criteria

September 23, 1999

First Posted (Estimate)

September 24, 1999

Study Record Updates

Last Update Posted (Estimate)

May 26, 2006

Last Update Submitted That Met QC Criteria

May 25, 2006

Last Verified

October 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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