Non Arthritic Anterior Ischemic Optic NeuropathyPhase 1/2NCT00372021
Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy
A Phase 1/2 study testing optic nerve neurotomy in people with Non Arthritic Anterior Ischemic Optic Neuropathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Non Arthritic Anterior Ischemic Optic Neuropathy
- What is being tested?
- optic nerve neurotomy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jan 2003to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-arthritic anterior ischemic optic nerve
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- optic nerve neurotomy
- Keywords
- non arthritic ischemic optic neuropathy, anterior ischemic optic neuropathy, Optic nerve Neurotomy
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optic nerve neurotomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Arthritic Anterior Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Masoud Soheilian, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372021
- Sponsor's protocol ID
- 8136
- Status last verified
- Nov 2002
- First submitted
- 5 Sep 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT00372021
- Acronym / sponsor ID
- 8136
- Keywords
- non arthritic ischemic optic neuropathy, anterior ischemic optic neuropathy, Optic nerve Neurotomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with non-arthritic anterior ischemic optic nerve
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optic nerve neurotomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masoud Soheilian, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing optic nerve neurotomy in people with Non Arthritic Anterior Ischemic Optic Neuropathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2006.