Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000126
Status:
UNKNOWN
Last Update Posted:
2006-05-26
First Post:
1999-09-23
Brief Title:
Ischemic Optic Neuropathy Decompression Trial Followup IONDT Followup
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 25000 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 427 percent of patients who received careful followup
NAION in both eyes has been reported in as few as 105 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 175 percent of patients developed bilateral disease at 1 year of followup and 345 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 25216 incidence of bilateral NAION in its randomized patients The incidence in the nonrandomized group 91 percent of whom had visual acuity better than 2064 is much lower at 4 percent 5136
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 patients visual field will be tested by using the Humphrey Perimeter
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 25000 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 427 percent of patients who received careful followup
NAION in both eyes has been reported in as few as 105 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 175 percent of patients developed bilateral disease at 1 year of followup and 345 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 25216 incidence of bilateral NAION in its randomized patients The incidence in the nonrandomized group 91 percent of whom had visual acuity better than 2064 is much lower at 4 percent 5136
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 patients visual field will be tested by using the Humphrey Perimeter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None