Ischemic Optic NeuropathyPhase 3NCT00000127
Ischemic Optic Neuropathy Decompression Trial (IONDT)
A Phase 3 study testing Optic Nerve Sheath Decompression Surgery in people with Ischemic Optic Neuropathy, run by National Eye Institute (NEI).
Trial summary
To assess the safety and efficacy of optic nerve sheath decompression surgery for non-arteritic ischemic optic neuropathy (NAION). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemic Optic Neuropathy
- What is being tested?
- Optic Nerve Sheath Decompression Surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 1992to Oct 1994
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
To assess the safety and efficacy of optic nerve sheath decompression surgery for non-arteritic ischemic optic neuropathy (NAION).
Read the 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.
- Conditions
- Ischemic Optic Neuropathy
- Being tested
- Optic Nerve Sheath Decompression Surgery
- Keywords
- Non-arteritic Ischemic Optic Neuropathy
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath Decompression SurgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startOct 1992
- Study completionOct 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000127
- Sponsor's protocol ID
- NEI-26
- Status last verified
- Sep 2009
- First submitted
- 23 Sep 1999
- Last updated
- 24 Mar 2010
- Results posted
- No
Publications
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.
PubMed 9620811Characteristics 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.
PubMed 8906027Scherer 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
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
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
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.
PubMed 7844872
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Optic Neuropathy Decompression Trial (IONDT)
- ClinicalTrials.gov ID
- NCT00000127
- Acronym / sponsor ID
- NEI-26
- Conditions
- Ischemic Optic Neuropathy
- Keywords
- Non-arteritic Ischemic Optic Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Oct 1992
- Study completion
- Oct 1994 (actual)
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic Nerve Sheath Decompression Surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Background: PubMed 9620811The 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.
- Background: PubMed 8906027Characteristics 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.
- BackgroundScherer 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
- BackgroundCrawley B; Scherer RW; Ischemic Optic Neuropathy Decompression Trial (IONDT): Participation in the IONDT. Race, gender and age. [Abstract]., Controlled Clinical Trials 1994;15:102S
- BackgroundCrawley 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
- Background: PubMed 7844872Optic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Optic Nerve Sheath Decompression Surgery in people with Ischemic Optic Neuropathy, run by National Eye Institute (NEI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000127, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2010.