Intermittent ExotropiaNCT02131792
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
A study testing Slanted recession of the lateral rectus muscle in people with Intermittent Exotropia, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Slanted recession of the lateral rectus muscle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Apr 2014
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
- Patients with follow up duration greater than 6 months
Who cannot join
- Patients with previous ocular or strabismus surgery
- Patients with ocular or neurologic pathologic conditions
- Follow up duration less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness; A Prospective Study
This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness
Read the detailed description
This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.
- Conditions
- Intermittent Exotropia
- Being tested
- Slanted recession of the lateral rectus muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slanted recession of the lateral rectus muscleProcedure or surgery
All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Rectus Muscle Slanted Recession | Experimental | Slanted recession of the lateral rectus muscle for the intermittent exotropia with convergence weakness Receives: Procedure: Slanted recession of the lateral rectus muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.
Measurement of deviation angle after slanted recession surgery was performed.
Measured: preop, 6months postop
Secondary outcomes (1)
Changes from baseline of near-distance difference after slanted recession surgery at 6 months
Measurement of stereopsis after slanted recession was performed.
Measured: preop, 6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Chun, Kyungpook National University Hospital
- Investigators
- Bo Young Chun, M.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131792
- Sponsor's protocol ID
- KNUH2014-02
- Status last verified
- May 2014
- First submitted
- 4 May 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness; A Prospective Study
- ClinicalTrials.gov ID
- NCT02131792
- Acronym / sponsor ID
- KNUH2014-02
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 May 2014 (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.
This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness
Detailed description
This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral Rectus Muscle Slanted Recession | Experimental | Procedure: Slanted recession of the lateral rectus muscleSlanted recession of the lateral rectus muscle for the intermittent exotropia with convergence weakness |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
- Patients with follow up duration greater than 6 months
Key exclusion criteria (3 listed)
- Patients with previous ocular or strabismus surgery
- Patients with ocular or neurologic pathologic conditions
- Follow up duration less than 6 months
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 |
|---|---|---|
| Slanted recession of the lateral rectus muscleAll patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group. | Procedure or surgery | Lateral Rectus Muscle Slanted Recession |
Primary outcome
Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.
Time frame: preop, 6months postop
Measurement of deviation angle after slanted recession surgery was performed.
1 secondary outcome
Changes from baseline of near-distance difference after slanted recession surgery at 6 months
Time frame: preop, 6 months postop
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 6 May 2014.
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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.
Bo Young Chun, M.D principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slanted recession of the lateral rectus muscle in people with Intermittent Exotropia, run by Kyungpook National University Hospital at 1 site in South Korea.
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 2 inclusion and 3 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 6 May 2014. 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 South Korea. 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.
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.
What does the primary outcome measure?
Changes from baseline of exodeviations angle after slanted recession surgery at 6 months. (time frame: preop, 6months postop). It is what the study was designed to measure, not a finding.
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 2014.