The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a five year study designed to assess the safety and efficacy of optic nerve sheath decompression surgery (ONDS) for non-arteritic ischemic optic neuropathy (NAION), diagnosed within one month of onset of visual symptoms. A standardized, common protocol for treatment and data collection will be used by all centers. This multicenter, randomized clinical trial is designed to compare differences in patients randomized to one of two treatment groups as follows: Treatment Group Treatment Sequences No of Patients 1. Test Treatment Optic Nerve Sheath Decompression Surgery 150 2. Control Treatment Standard Medical Care (no surgery) 150 The primary hypothesis to be addressed by this trial are: Is treatment with ONDS more effective than standard care in 1) restoring or 2) maintaining central visual acuity in patients with NAION? The primary outcome for this trial (change in visual acuity) will be measured using the New York Lighthouse chart. A gain of three or more lines of visual acuity (doubling of the visual angle) will be considered improvement. Secondary outcomes include: Change in peripheral visual function (using standard Goldmann perimetry); and incidence of ophthalmic and systemic complications. Patients will be recruited over a two year period and followed for a minimum of one year. Study Centers will include a Chairman's Center, 15 Clinical Centers, and centralized facilities, including a Coordinating Center, a Reading Center, and a Project Office at the National Eye Institute.

National Institute of Health (NIH)
National Eye Institute (NEI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Vision Research and Training Committee (VSN)
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University of Maryland Baltimore
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United States
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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
Feldon, Steven E (2004) Computerized expert system for evaluation of automated visual fields from the Ischemic Optic Neuropathy Decompression Trial: methods, baseline fields, and six-month longitudinal follow-up. Trans Am Ophthalmol Soc 102:269-303
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
Dickersin, Kay; Scherer, Roberta; Suci, Eunike Sri Tyas et al. (2002) Problems with indexing and citation of articles with group authorship. JAMA 287:2772-4
(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

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