Children With TorticollisNCT05882552
Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
A study testing Tilted Gaze Target Tast and Conventional Examination Methods in people with Children With Torticollis, run by Tianjin Eye Hospital.
Trial summary
This study is a prospective, randomized, double-blind cohort study aimed at assessing the accuracy of the preoperative tilted gaze target test in predicting the degree of improvement in compensatory head position after surgery in children with superior oblique muscle palsy. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Children With Torticollis
- What is being tested?
- Tilted Gaze Target Tast and Conventional Examination Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 31 Dec 2024
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 and 8 years old.
- History of torticollis less than 5 years.
- Ability to cooperate with basic examinations at the Tianjin Ophthalmology Strabismus and Pediatric Ophthalmology Clinic.
- Complete clinical information available.
- Signed informed consent.
Who cannot join
- Both eyes cannot look at the same time or alternately
- Children with ocular disease other than oculomotor eye disease.
- Clearly defined systemic developmental abnormalities: Down syndrome, microcephaly, autism, Leber syndrome, central visual impairment, etc.
- Children who cannot cooperate with the examination due to age or other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Accuracy of Applying the Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
This study is a prospective, randomized, double-blind cohort study aimed at assessing the accuracy of the preoperative tilted gaze target test in predicting the degree of improvement in compensatory head position after surgery in children with superior oblique muscle palsy.
Read the detailed description
This is a prospective, randomized, double-blind cohort study conducted from May 2023 to April 2024. The study aims to evaluate the effectiveness of a non-human contact gaze tilt test in the diagnosis of children with superior oblique Muscle Palsy. Patients who met the inclusion criteria for outpatient and inpatient ophthalmic surgery for strabismus and pediatric ophthalmology were enrolled after signing a written informed consent. The gaze tilt test was added to the normal treatment process and performed by a professional ophthalmologist who was not involved in the treatment process. The test involved playing a small animated video with a visual mobile device at a distance of 33 cm and 3 m, respectively, to determine the optimal angle of head position improvement and the spatial tilt angle of the screen relative to the orthostatic position. A third-party analysis of the data was performed to identify myotonic and oculocutaneous tilts and compared with the results of the conventional test. The study aims to clarify the authenticity, reliability, and practicality of the gaze object tilt test in diagnosing and treating oculocutaneous squint.
- Conditions
- Children With Torticollis
- Being tested
- Tilted Gaze Target Tast, Conventional Examination Methods
- Keywords
- tilted gaze, superior oblique muscle palsy, strabismus, diagnosis, projection
- Medical subject headings
- Strabismus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tilted Gaze Target TastDiagnostic test
Tilted gaze target tast is playing a small animated video with a visual mobile device at a distance of 33 cm and 3 m, respectively, to determine the optimal angle of head position improvement and the spatial tilt angle of the screen relative to the orthostatic position.It will be conducted during the first visit. Preoperative intervention will also be conducted before surgery. Postoperative interventions will be conducted at one day, one month, and six months after surgery.
Conventional Examination MethodsDiagnostic test
The conventional examination methods include oculomotor examination, Bielschowsky head tilt test, alternate prism cover test, prism adaptation test, and monocular cover test. They will be conducted during the first visit. Preoperative intervention will also be conducted before surgery.Postoperative interventions will be conducted at one day, one month, and six months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tilted Gaze Target Test+Conventional Examinations | Experimental | Tilted gaze target test is before conventional examination Receives: Diagnostic Test: Tilted Gaze Target Tast; Diagnostic Test: Conventional Examination Methods |
| Conventional Examinations +Tilted Gaze Target Test | Active comparator | Conventional examination is before tilted gaze target test Receives: Diagnostic Test: Tilted Gaze Target Tast; Diagnostic Test: Conventional Examination Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of test in predicting the degree of improvement in head position after surgery
Pearson correlation and paired sample difference analyses were conducted to compare the results of the preoperative gaze object tilt test (tilted post-tilt head angle/untilted head angle) with the postoperative head angle measurements taken at 1 day, 1 month, and 6 months, relative to the preoperative untilted head angle.
Measured: 6 Months
Secondary outcomes (2)
Comparison with the traditional combined diagnosis of monocular masking, eye movement and Bielschowsky head-tilting test，the positive predictive value of tilt test in the diagnosis and treatment of oculomotor-derived torticollis
Positive predictive value= (True Positives / (True Positives + False Positives)) * 100
Measured: 1Week
Comparison with the traditional combined diagnosis of monocular masking, eye movement and Bielschowsky head-tilting test，the negative predictive value of tilt test in the diagnosis and treatment of oculomotor-derived torticollis
Negative predictive value =(True Negatives / (True Negatives + False Negatives)) * 100
Measured: 1Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Children With TorticollisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The enrolled study participants will be randomly assigned to two groups and undergo a crossover design in which they will sequentially undergo the tilted gaze target test and conventional examination methods, including oculomotor examination, Bielschowsky tilt test, alternate prism cover test, prism adaptation test, and monocular cover test.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, Ph.D, Study chair, Tianjin Eye HospitalXiaotong Li, M.D., Study director, Tianjin Eye HospitalTiange Liu, MA.Sc, Principal investigator, Nankai UniversityZhen Li, MA.Sc, Principal investigator, Nankai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882552
- Sponsor's protocol ID
- 2023018
- Status last verified
- May 2023
- First submitted
- 6 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McLean JM. Direct Surgery of Underacting Oblique Muscles. Trans Am Ophthalmol Soc. 1948;46:633-51. No abstract available.
PubMed 16693495PARKS MM. Isolated cyclovertical muscle palsy. AMA Arch Ophthalmol. 1958 Dec;60(6):1027-35. doi: 10.1001/archopht.1958.00940081047008. No abstract available.
PubMed 13593934Hertle RW. Diagnosis of isolated cyclovertical muscle overaction using a modification of the Parks' Three-Step Test. Strabismus. 1993;1(3):107-20. doi: 10.3109/09273979309057131.
PubMed 21314550Khorrami-Nejad M, Akbari MR, Kangari H, Akbarzadeh Baghban A, Masoomian B, Ranjbar-Pazooki M. Abnormal Head Posture in Unilateral Superior Oblique Palsy. J Binocul Vis Ocul Motil. 2021 Jan-Mar;71(1):16-23. doi: 10.1080/2576117X.2020.1845561. Epub 2020 Dec 16.
PubMed 33326345Chung SA, Yim SY, Park A. Sternocleidomastoid muscle asymmetry in unilateral congenital superior oblique palsy. Eye (Lond). 2021 Jul;35(7):1954-1960. doi: 10.1038/s41433-020-01205-2. Epub 2020 Sep 30.
PubMed 32999476
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Applying the Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
- ClinicalTrials.gov ID
- NCT05882552
- Acronym / sponsor ID
- 2023018
- Conditions
- Children With Torticollis
- Keywords
- tilted gaze, superior oblique muscle palsy, strabismus, diagnosis, projection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 May 2023 (actual)
- 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 is a prospective, randomized, double-blind cohort study aimed at assessing the accuracy of the preoperative tilted gaze target test in predicting the degree of improvement in compensatory head position after surgery in children with superior oblique muscle palsy.
Detailed description
This is a prospective, randomized, double-blind cohort study conducted from May 2023 to April 2024. The study aims to evaluate the effectiveness of a non-human contact gaze tilt test in the diagnosis of children with superior oblique Muscle Palsy. Patients who met the inclusion criteria for outpatient and inpatient ophthalmic surgery for strabismus and pediatric ophthalmology were enrolled after signing a written informed consent. The gaze tilt test was added to the normal treatment process and performed by a professional ophthalmologist who was not involved in the treatment process. The test involved playing a small animated video with a visual mobile device at a distance of 33 cm and 3 m, respectively, to determine the optimal angle of head position improvement and the spatial tilt angle of the screen relative to the orthostatic position. A third-party analysis of the data was performed to identify myotonic and oculocutaneous tilts and compared with the results of the conventional test. The study aims to clarify the authenticity, reliability, and practicality of the gaze object tilt test in diagnosing and treating oculocutaneous squint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The enrolled study participants will be randomly assigned to two groups and undergo a crossover design in which they will sequentially undergo the tilted gaze target test and conventional examination methods, including oculomotor examination, Bielschowsky tilt test, alternate prism cover test, prism adaptation test, and monocular cover test.
| Arm | Type | Receives |
|---|---|---|
| Tilted Gaze Target Test+Conventional Examinations | Experimental | Diagnostic Test: Tilted Gaze Target Tast, Diagnostic Test: Conventional Examination MethodsTilted gaze target test is before conventional examination |
| Conventional Examinations +Tilted Gaze Target Test | Active comparator | Diagnostic Test: Tilted Gaze Target Tast, Diagnostic Test: Conventional Examination MethodsConventional examination is before tilted gaze target test |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 1 and 8 years old.
- History of torticollis less than 5 years.
- Ability to cooperate with basic examinations at the Tianjin Ophthalmology Strabismus and Pediatric Ophthalmology Clinic.
- Complete clinical information available.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Both eyes cannot look at the same time or alternately
- Children with ocular disease other than oculomotor eye disease.
- Clearly defined systemic developmental abnormalities: Down syndrome, microcephaly, autism, Leber syndrome, central visual impairment, etc.
- Children who cannot cooperate with the examination due to age or other reasons.
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 |
|---|---|---|
| Tilted Gaze Target TastTilted gaze target tast is playing a small animated video with a visual mobile device at a distance of 33 cm and 3 m, respectively, to determine the optimal angle of head position improvement and the spatial tilt angle of the screen relative to the orthostatic position.It will be conducted during the first visit. Preoperative intervention will also be conducted before surgery. Postoperative interventions will be conducted at one day, one month, and six months after surgery. | Diagnostic test | Conventional Examinations +Tilted Gaze Target Test, Tilted Gaze Target Test+Conventional Examinations |
| Conventional Examination MethodsThe conventional examination methods include oculomotor examination, Bielschowsky head tilt test, alternate prism cover test, prism adaptation test, and monocular cover test. They will be conducted during the first visit. Preoperative intervention will also be conducted before surgery.Postoperative interventions will be conducted at one day, one month, and six months after surgery. | Diagnostic test | Conventional Examinations +Tilted Gaze Target Test, Tilted Gaze Target Test+Conventional Examinations |
Primary outcome
The accuracy of test in predicting the degree of improvement in head position after surgery
Time frame: 6 Months
Pearson correlation and paired sample difference analyses were conducted to compare the results of the preoperative gaze object tilt test (tilted post-tilt head angle/untilted head angle) with the postoperative head angle measurements taken at 1 day, 1 month, and 6 months, relative to the preoperative untilted head angle.
2 secondary outcomes
Comparison with the traditional combined diagnosis of monocular masking, eye movement and Bielschowsky head-tilting test，the positive predictive value of tilt test in the diagnosis and treatment of oculomotor-derived torticollis
Time frame: 1Week
Comparison with the traditional combined diagnosis of monocular masking, eye movement and Bielschowsky head-tilting test，the negative predictive value of tilt test in the diagnosis and treatment of oculomotor-derived torticollis
Time frame: 1Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 16693495McLean JM. Direct Surgery of Underacting Oblique Muscles. Trans Am Ophthalmol Soc. 1948;46:633-51. No abstract available.
- Background: PubMed 13593934PARKS MM. Isolated cyclovertical muscle palsy. AMA Arch Ophthalmol. 1958 Dec;60(6):1027-35. doi: 10.1001/archopht.1958.00940081047008. No abstract available.
- Background: PubMed 21314550Hertle RW. Diagnosis of isolated cyclovertical muscle overaction using a modification of the Parks' Three-Step Test. Strabismus. 1993;1(3):107-20. doi: 10.3109/09273979309057131.
- Background: PubMed 33326345Khorrami-Nejad M, Akbari MR, Kangari H, Akbarzadeh Baghban A, Masoomian B, Ranjbar-Pazooki M. Abnormal Head Posture in Unilateral Superior Oblique Palsy. J Binocul Vis Ocul Motil. 2021 Jan-Mar;71(1):16-23. doi: 10.1080/2576117X.2020.1845561. Epub 2020 Dec 16.
- Background: PubMed 32999476Chung SA, Yim SY, Park A. Sternocleidomastoid muscle asymmetry in unilateral congenital superior oblique palsy. Eye (Lond). 2021 Jul;35(7):1954-1960. doi: 10.1038/s41433-020-01205-2. Epub 2020 Sep 30.
- Individual participant dataSharing planned: No
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.
Wei Zhang, Ph.D study chair
Tianjin Eye Hospital
Xiaotong Li, M.D. study director
Tianjin Eye Hospital
Tiange Liu, MA.Sc principal investigator
Nankai University
Questions about this trial
What is this clinical trial studying?
A study testing Tilted Gaze Target Tast and Conventional Examination Methods in people with Children With Torticollis, run by Tianjin Eye Hospital.
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 5 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 9 Jun 2023. 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.
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 Xiaotong Li, M.D. (+86(22)27313336, 15942046916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of test in predicting the degree of improvement in head position after surgery (time frame: 6 Months). 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 NCT05882552, which also lists 5 linked publications.
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 9 Jun 2023.