Ischemic Optic Neuropathy Decompression Trial (IONDT)
Primary Purpose
Ischemic Optic Neuropathy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Optic Nerve Sheath Decompression Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Optic Neuropathy focused on measuring Non-arteritic Ischemic Optic Neuropathy
Eligibility Criteria
Men and women age 50 years or older, with acute NAION and visual symptoms for 14 days or less since the onset of symptoms, and visual acuity worse than or equal to 20/64 were eligible for randomization.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000127
First Posted
September 23, 1999
Last Updated
March 23, 2010
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00000127
Brief Title
Ischemic Optic Neuropathy Decompression Trial (IONDT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
To assess the safety and efficacy of optic nerve sheath decompression surgery for non-arteritic ischemic optic neuropathy (NAION).
Detailed Description
Non-arteritic ischemic optic neuropathy (NAION), the most common cause of acute optic nerve disease in older persons, causes permanent and severe visual loss. Visual function can be impaired through decreased central visual acuity or peripheral field loss, or both. NAION strikes both eyes in up to 40 percent of affected patients. The incidence of NAION has been estimated at 2.3 per 100,000 persons over the age of 50 years and 0.54 per 100,000 for all ages. Estimates of the number of new cases seen each year in the United States range from a low of approximately 1,500 to a high of 6,000.
NAION has been hypothesized to be caused by vascular insufficiency leading to optic nerve head ischemia. There is general agreement that NAION results from transient non-perfusion of nutrient vessels. The wide range of visual field defects and visual loss with NAION can be explained by the extent and number of the blood vessels involved.
Anatomical factors appear to contribute to the vascular event initiating NAION. Clinically, the number of discs congenitally lacking a physiological cup in eyes with NAION is higher than expected. Presumably, in eyes with NAION, these discs have small scleral openings that crowd the nerve fibers as they pass through the restricted space in the optic disc and lamina cribrosa, thereby predisposing to an ischemic spiral.
One current theory holds that NAION begins as a minor ischemic event that later progresses to a major infarction due to congenitally anomalous optic nerves. The inciting ischemic event leads to local anterior nerve edema, and this causes further ischemia.
Optic nerve sheath decompression surgery was reported in 1989 to be of benefit to patients with NAION. The presumed mechanism of action in optic nerve decompression surgery revolved around restoration of impaired blood flow to the optic nerve through reduction of the pressure around the nerve.
The Ischemic Optic Neuropathy Decompression Trial (IONDT) was a randomized clinical trial designed to compare the improvements in visual acuity at 6 months in patients assigned to receive surgery with optic nerve sheath decompression with those assigned to careful followup. A cohort of patients, with a baseline visual acuity of better than 20/64 are also being followed to better understand the natural history of the disease, including second eye involvement.
Enrollment began in October 1992. Randomization was stratified by clinic, and patients had an equal probability of assignment to surgery or careful followup. All patients are being followed for a minimum of 2 years.
The primary outcome is a change of three lines or more in visual acuity at the 6-month followup visit compared with visual acuity measured at the randomization visit.
Secondary outcomes include a change in visual acuity beyond 6 months, change in peripheral visual function as measured by automated Humphrey perimetry, local and systemic side effects from treatment, change in quality of life, and other associated morbidity and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Optic Neuropathy
Keywords
Non-arteritic Ischemic Optic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Optic Nerve Sheath Decompression Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women age 50 years or older, with acute NAION and visual symptoms for 14 days or less since the onset of symptoms, and visual acuity worse than or equal to 20/64 were eligible for randomization.
12. IPD Sharing Statement
Citations:
PubMed Identifier
9620811
Citation
The ischemic optic neuropathy decompression trial (IONDT): design and methods. Control Clin Trials. 1998 Jun;19(3):276-96. doi: 10.1016/s0197-2456(98)00003-8.
Results Reference
background
PubMed Identifier
8906027
Citation
Characteristics of patients with nonarteritic anterior ischemic optic neuropathy eligible for the Ischemic Optic Neuropathy Decompression Trial. Arch Ophthalmol. 1996 Nov;114(11):1366-74. doi: 10.1001/archopht.1996.01100140566007.
Results Reference
background
Citation
Scherer RW; Crawley B; Abstracts for the Ischemic Optic Neuropathy Study Group; Responses to ethical and other questions on a knowledge assessment form for a multicenter trial. [Abstract]., Controlled Clinical Trials 1993;14:442S
Results Reference
background
Citation
Crawley B; Scherer RW; Ischemic Optic Neuropathy Decompression Trial (IONDT): Participation in the IONDT. Race, gender and age. [Abstract]., Controlled Clinical Trials 1994;15:102S
Results Reference
background
Citation
Crawley B; Waring MT; Scherer RW; Coordinating Center for the Ischemic Optic Neuropathy Decompression Trial (IONDT): IONDT tracking system: Where is form 2034 for patient ICMORE and who is responsible? [Abstract]., Controlled Clinical Trials 1994;15:93S
Results Reference
background
PubMed Identifier
7844872
Citation
Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. The Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA. 1995 Feb 22;273(8):625-32.
Results Reference
background
Citation
Kaufman D; Ischemic Optic Neuropathy Decompression Trial Study Group; Optic nerve decompression surgery for nonarteritic ischemic optic neuropathy (NAION is not effective and could be harmful: Results of the Ischemic Optic Neuropathy Decompression Trial (IONDT). [Abstract]., Invest Ophthalmol Vis Sci 1995;36:S196
Results Reference
background
Links:
URL
http://www.nei.nih.gov/news/clinicalalerts/alert-iondt.asp
Description
Clinical Alert to Ophthalmologists and Neurologists
URL
http://www.nei.nih.gov/news/pressreleases/iondtpressrelease.asp
Description
NEI Press Release-Eye Surgery Found Ineffective and May be Harmful -- Study Halted
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Ischemic Optic Neuropathy Decompression Trial (IONDT)
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