Inferior Oblique Muscle OveractivityPhase 1/2NCT00893321
Comparison of Inferior Oblique Muscle Recession and Myectomy
A Phase 1/2 study testing Inferior Oblique Muscle Recession and Myectomy in people with Inferior Oblique Muscle Overactivity, run by Shahid Beheshti University of Medical Sciences.
Trial summary
The purpose of this study is to compare muscle recession and myectomy on inferior oblique muscle overactivity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inferior Oblique Muscle Overactivity
- What is being tested?
- Inferior Oblique Muscle Recession and Myectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Overactivity of Inferior Oblique Muscle >= 2
Who cannot join
- Nystagmus
- History of vertical muscle operation
- Mechanical limitation
- Eye disease
- Paralysis
About this study
The purpose of this study is to compare muscle recession and myectomy on inferior oblique muscle overactivity.
- Conditions
- Inferior Oblique Muscle Overactivity
- Being tested
- Inferior Oblique Muscle Recession and Myectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Oblique Muscle Recession and MyectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Inferior Oblique Muscle Recession and Myectomy | Other | Not described Receives: Procedure: Inferior Oblique Muscle Recession and Myectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Oblique Muscle OveractivityStudies 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
- Who is masked
- Participant
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893321
- Sponsor's protocol ID
- 8701
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inferior Oblique Muscle Recession and Myectomy
- ClinicalTrials.gov ID
- NCT00893321
- Acronym / sponsor ID
- 8701
- Conditions
- Inferior Oblique Muscle Overactivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 6 May 2009 (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.
The purpose of this study is to compare muscle recession and myectomy on inferior oblique muscle overactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inferior Oblique Muscle Recession and Myectomy | Other | Procedure: Inferior Oblique Muscle Recession and Myectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Overactivity of Inferior Oblique Muscle >= 2
Key exclusion criteria (5 listed)
- Nystagmus
- History of vertical muscle operation
- Mechanical limitation
- Eye disease
- Paralysis
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 |
|---|---|---|
| Inferior Oblique Muscle Recession and Myectomy | Procedure or surgery | Inferior Oblique Muscle Recession and Myectomy |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inferior Oblique Muscle Recession and Myectomy in people with Inferior Oblique Muscle Overactivity, run by Shahid Beheshti University of Medical Sciences.
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 5 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: status not confirmed, as of the sponsor's last update on 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 6 May 2009.