The Ischemic Optic Neuropathy Decompression Trial (IONDT), the first multicenter, prospective randomized controlled trial of newly diagnosed patients with non-artertic anterior ischemic optic neuropathy (NAION), found that optic nerve decompression surgery (ONDS), when compared to careful foIlowup, is not effective and may be harmful to a patient's visual acuity. Randomized patients have been followed for 1 to 3 years (median = 1.51 years) since onset of symptoms. Patients with NAION whose vision was better than 20164 were not randomized to treatment but were followed as a natural history cohort for the same length of time. The goal of the IONDT Followup Study is to follow all patients enrolled in the IONDT to learn more about the natural history of NAION, specifically: incidence of NAION in the second eye; changes in visual acuity over time in the study and fellow eyes; incidence of systemic disease; health-related quality of life (QOL); medication use, including aspirin; and risk factors for ocular and systemic events occurring after enrollment. An additional goal of the Followup Study will be to analyze all visual fields and fundus photographs accumulated during the IONDT and IONDT Followup Study. IONDT patients will be followed at all 24 participating Clinical Centers an additional four years at annual visits related both to the effect of ONDS and the natural history of NAION. Examinations will consist of ophthalmic examinations, measurement of visual acuity and visual field. In the event of NAION occurring in the second eye, a special visit will be scheduled at the Clinical Center, which will be similar to annual visits with the addition of fundus photographs. At three month intervals between annual visits, a coordinator located at the Coordinating Center will telephone patients to maintain high rates of patient followup, ensure that annual visits take place, and determine whether any ophthalmic or medical events have occurred between annual visits.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY009545-07
Application #
2872362
Study Section
Special Emphasis Panel (ZEY1-VSN (02))
Project Start
1992-02-19
Project End
2002-01-31
Budget Start
1999-02-01
Budget End
2000-01-31
Support Year
7
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Maryland Baltimore
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
003255213
City
Baltimore
State
MD
Country
United States
Zip Code
21201
Scherer, Roberta W; Feldon, Steven E; Levin, Lori et al. (2008) Visual fields at follow-up in the Ischemic Optic Neuropathy Decompression Trial: evaluation of change in pattern defect and severity over time. Ophthalmology 115:1809-17
Newman, Nancy J (2007) The ischemic optic neuropathy decompression trial. Arch Ophthalmol 125:1568-70
Feldon, Steven E; Levin, Lori; Scherer, Roberta W et al. (2006) Development and validation of a computerized expert system for evaluation of automated visual fields from the Ischemic Optic Neuropathy Decompression Trial. BMC Ophthalmol 6:34
Scherer, Roberta; Zhu, Qi; Langenberg, Patricia et al. (2003) Comparison of information obtained by operative note abstraction with that recorded on a standardized data collection form. Surgery 133:324-30
Feldon, Steven E; Scherer, Roberta W; Hooper, Frank J et al. (2003) Surgical quality assurance in the Ischemic Optic Neuropathy Decompression Trial (IONDT). Control Clin Trials 24:294-305
Newman, Nancy J; Scherer, Roberta; Langenberg, Patricia et al. (2002) The fellow eye in NAION: report from the ischemic optic neuropathy decompression trial follow-up study. Am J Ophthalmol 134:317-28
(2000) Ischemic Optic Neuropathy Decompression Trial: twenty-four-month update. Arch Ophthalmol 118:793-8
(1998) The ischemic optic neuropathy decompression trial (IONDT): design and methods. Control Clin Trials 19:276-96
Crawley, B; Scherer, R; Langenberg, P et al. (1997) Participation in the Ischemic Optic Neuropathy Decompression Trial: sex, race, and age. Ophthalmic Epidemiol 4:157-73
(1996) Characteristics of patients with nonarteritic anterior ischemic optic neuropathy eligible for the Ischemic Optic Neuropathy Decompression Trial. Arch Ophthalmol 114:1366-74

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