Moderate Intermittent ExotropiaSOMIXNCT02736526
Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia
A study testing recession or resection of the horizontal extraocular muscles in people with Moderate Intermittent Exotropia, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Moderate Intermittent Exotropia
- What is being tested?
- recession or resection of the horizontal extraocular muscles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2022
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To correspond the definition of IXT: monocular or binocular alternative exotropia, exodeviation at distance for 15 prism diopters at least, can control the normal ocular alignment, normal ocular movements.
- Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis.
- Age at from 5 to 18 years, sex unlimited.
- No treatment for IXT previously (including surgical and non-surgical treatment).
- No amblyopia.
- Signed informed consent form voluntarily.
Who cannot join
- Accompanied with ocular organic diseases.
- Accompanied with systemic diseases (e.g. nervous system disease).
- Unable to regular follow-up (e.g. from countryside and outlying district).
- Investigators concluded that should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Jianhua Yan, M.D., 86-18922103805, yan2011@tom.com
About this study
Official title: Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
The purpose of this study is to determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia.
- Conditions
- Moderate Intermittent Exotropia
- Being tested
- recession or resection of the horizontal extraocular muscles
- Keywords
- moderate intermittent exotropia, surgical treatment, observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recession or resection of the horizontal extraocular musclesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Experimental | The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial. Receives: Procedure: recession or resection of the horizontal extraocular muscles |
| Observation only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular alignment (Prism alternative cover test)
Measured: 5 years
Binocular stereopsis at distance and near (Random dot stereopsis test)
Measured: 5 years
Secondary outcomes (2)
Newcastle control scores
Measured: 5 years
The intermittent exotropia questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Shen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736526
- Sponsor's protocol ID
- ZX201304
- Acronym
- SOMIX
- Status last verified
- Dec 2021
- First submitted
- 3 Apr 2016
- Last updated
- 22 Dec 2021
- Results posted
- No
Publications
Shen T, Chen J, Kang Y, Deng D, Lin X, Wu H, Li J, Wang Z, Qiu X, Jin L, Yan J. Surgical treatment versus observation in moderate intermittent exotropia (SOMIX): study protocol for a randomized controlled trial. Trials. 2023 Mar 1;24(1):153. doi: 10.1186/s13063-023-07189-0.
PubMed 36855155
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT02736526
- Acronym / sponsor ID
- SOMIX / ZX201304
- Conditions
- Moderate Intermittent Exotropia
- Keywords
- moderate intermittent exotropia, surgical treatment, observation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Apr 2016 (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 determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Experimental | Procedure: recession or resection of the horizontal extraocular musclesThe recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial. |
| Observation only | No intervention | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- To correspond the definition of IXT: monocular or binocular alternative exotropia, exodeviation at distance for 15 prism diopters at least, can control the normal ocular alignment, normal ocular movements.
- Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis.
- Age at from 5 to 18 years, sex unlimited.
- No treatment for IXT previously (including surgical and non-surgical treatment).
- No amblyopia.
Key exclusion criteria (4 listed)
- Accompanied with ocular organic diseases.
- Accompanied with systemic diseases (e.g. nervous system disease).
- Unable to regular follow-up (e.g. from countryside and outlying district).
- Investigators concluded that should be excluded.
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 |
|---|---|---|
| recession or resection of the horizontal extraocular muscles | Procedure or surgery | Surgical treatment |
Primary outcome
Ocular alignment (Prism alternative cover test)
Time frame: 5 years
Binocular stereopsis at distance and near (Random dot stereopsis test)
Time frame: 5 years
2 secondary outcomes
Newcastle control scores
Time frame: 5 years
The intermittent exotropia questionnaire
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 36855155Shen T, Chen J, Kang Y, Deng D, Lin X, Wu H, Li J, Wang Z, Qiu X, Jin L, Yan J. Surgical treatment versus observation in moderate intermittent exotropia (SOMIX): study protocol for a randomized controlled trial. Trials. 2023 Mar 1;24(1):153. doi: 10.1186/s13063-023-07189-0.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recession or resection of the horizontal extraocular muscles in people with Moderate Intermittent Exotropia, run by Sun Yat-sen University at 1 site in China.
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 6 inclusion and 4 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 22 Dec 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Shen, M.D. (86-13824449536, shentao@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular alignment (Prism alternative cover test) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736526, which also lists 1 linked publication.
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 22 Dec 2021.