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Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy

Primary Purpose

Non Arthritic Anterior Ischemic Optic Neuropathy

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
optic nerve neurotomy
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Arthritic Anterior Ischemic Optic Neuropathy focused on measuring non arthritic ischemic optic neuropathy, anterior ischemic optic neuropathy, Optic nerve Neurotomy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with non-arthritic anterior ischemic optic nerve

Exclusion Criteria:

  • Visual acuity more than 20/200
  • Other intra occular operations
  • Passing more than 4 weeks of the problem
  • Arthritic anterior ischemic optic nerve
  • Age under 50 years
  • Consumption of previous pharmaceutical treatment

Sites / Locations

  • Ophthalmic Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 5, 2006
Last Updated
October 11, 2006
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00372021
Brief Title
Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
Non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual loss due to optic nerve involvement in patients above 50 years old. As this problem can be considered as a sclera out let syndrome an there is no effective and successful treatment for it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to achieve acceptable treating outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Arthritic Anterior Ischemic Optic Neuropathy
Keywords
non arthritic ischemic optic neuropathy, anterior ischemic optic neuropathy, Optic nerve Neurotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
optic nerve neurotomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non-arthritic anterior ischemic optic nerve Exclusion Criteria: Visual acuity more than 20/200 Other intra occular operations Passing more than 4 weeks of the problem Arthritic anterior ischemic optic nerve Age under 50 years Consumption of previous pharmaceutical treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy

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