Clinical trial NCT05882552: Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
Official title: The Accuracy of Applying the Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children With Torticollis
Keywords: tilted gaze
superior oblique muscle palsy
strabismus
diagnosis
projection
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy of test in predicting the degree of improvement in head position after surgery
timeFrame: 6 Months
Secondary outcomes:
measure: 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
timeFrame: 1Week
measure: 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
timeFrame: 1Week
Other outcomes:
measure: The correlation between tilted gaze target test and Bielschowsky's head tilt test
timeFrame: 6 Months
measure: The correlation between the tilt angle and the degree of vertical and rotational strabismus
timeFrame: 6 Months
Locations:
Study officials:
affiliation: Tianjin Eye Hospital
name: Wei Zhang, Ph.D
role: STUDY_CHAIR
affiliation: Tianjin Eye Hospital
name: Xiaotong Li, M.D.
role: STUDY_DIRECTOR
affiliation: Nankai University
name: Tiange Liu, MA.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Nankai University
name: Zhen Li, MA.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: McLean JM. Direct Surgery of Underacting Oblique Muscles. Trans Am Ophthalmol Soc. 1948;46:633-51. No abstract available.
citation: PARKS MM. Isolated cyclovertical muscle palsy. AMA Arch Ophthalmol. 1958 Dec;60(6):1027-35. doi: 10.1001/archopht.1958.00940081047008. No abstract available.
citation: Hertle 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.
citation: Khorrami-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.
citation: Chung 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.