Children With Torticollis
Conditions
Keywords
tilted gaze, superior oblique muscle palsy, strabismus, diagnosis, projection
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTTilted Gaze Target Tast
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.
DIAGNOSTIC_TESTConventional Examination Methods
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.
Sponsors
Tianjin Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
During the procedure, the participants will not be informed of the results of the gaze tilt test. The tilted gaze target test will be conducted by a professional ophthalmologist who is not involved in the consultation and is unaware of the actual diagnosis of the study participants. The investigators will ensure that the normal consultation process is followed without being informed of the results of the gaze tilt test. The statistical analysis will be performed by a third-party outcomes assessor.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The accuracy of test in predicting the degree of improvement in head position after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1Week | Positive predictive value= (True Positives / (True Positives + False Positives)) \* 100 |
| 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 | 1Week | Negative predictive value =(True Negatives / (True Negatives + False Negatives)) \* 100 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The correlation between tilted gaze target test and Bielschowsky's head tilt test | 6 Months | Pearson correlation and paired sample difference analyses were conducted to tilted gaze target test and Bielschowsky's head tilt test results |
| The correlation between the tilt angle and the degree of vertical and rotational strabismus | 6 Months | Pearson correlation and paired sample difference analyses were conducted to the correlation between the tilt angle and the degree of vertical and rotational strabismus |
Contacts
Primary ContactXiaotong Li, M.D.
Backup ContactYatu Guo, Ph.D
Outcome results
None listed