NCT00000127

Brief Summary

To assess the safety and efficacy of optic nerve sheath decompression surgery for non-arteritic ischemic optic neuropathy (NAION).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1992

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1992

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1994

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

March 24, 2010

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

March 23, 2010

Conditions

Ischemic Optic Neuropathy

Keywords

Non-arteritic Ischemic Optic Neuropathy

Interventions

Optic Nerve Sheath Decompression SurgeryPROCEDURE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 9620811BACKGROUND

  • Characteristics 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.

    PMID: 8906027BACKGROUND

  • Scherer 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 7844872BACKGROUND

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

October 1, 1992

Study Completion

October 1, 1994

Last Updated

March 24, 2010

Record last verified: 2009-09