ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL

Project: Research project

Description

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,
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 150 Decompression
2. Control Treatment Standard Medical Care 150 (no surgery) The primary hypothesis to be addressed by this trial is whether treatment
with ONDS is 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, 26 Clinical Centers, and
centralized facilities, including a Coordinating Center, a Reading Center,
and a Project Office at the National Eye Institute.
StatusFinished
Effective start/end date6/15/9211/30/00

Funding

  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health: $44,071.00
  • National Institutes of Health: $6,344.00
  • National Institutes of Health: $83,770.00
  • National Institutes of Health

Fingerprint

Ischemic Optic Neuropathy
Decompression
Optic Nerve
Visual Acuity
National Eye Institute (U.S.)
Therapeutics
Visual Field Tests
Clinical Protocols
Reading
Randomized Controlled Trials
Safety
Incidence

ASJC

  • Medicine(all)