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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilted Gaze Target Test+Conventional Examinations | Experimental | Tilted gaze target test is before conventional examination |
|
| Conventional Examinations +Tilted Gaze Target Test | Active Comparator | Conventional examination is before tilted gaze target test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilted Gaze Target Tast | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1Week |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between tilted gaze target test and Bielschowsky's head tilt test | Pearson correlation and paired sample difference analyses were conducted to tilted gaze target test and Bielschowsky's head tilt test results | 6 Months |
| The correlation between the tilt angle and the degree of vertical and rotational strabismus |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Li, M.D. | Contact | +86(22)27313336 | 15942046916@163.com | |
| Yatu Guo, Ph.D | Contact | +86(22)27313336 | yatuguo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, Ph.D | Tianjin Eye Hospital | Study Chair |
| Xiaotong Li, M.D. | Tianjin Eye Hospital | Study Director |
| Tiange Liu, MA.Sc |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16693495 | Background | McLean JM. Direct Surgery of Underacting Oblique Muscles. Trans Am Ophthalmol Soc. 1948;46:633-51. No abstract available. | |
| 13593934 | Background | PARKS MM. Isolated cyclovertical muscle palsy. AMA Arch Ophthalmol. 1958 Dec;60(6):1027-35. doi: 10.1001/archopht.1958.00940081047008. No abstract available. |
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| ID | Term |
|---|---|
| D013285 | Strabismus |
| D004194 | Disease |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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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.
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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.
|
| Conventional Examination Methods | Diagnostic 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. |
|
| 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 |
| 1Week |
Pearson correlation and paired sample difference analyses were conducted to the correlation between the tilt angle and the degree of vertical and rotational strabismus |
| 6 Months |
| Nankai University |
| Principal Investigator |
| Zhen Li, MA.Sc | Nankai University | Principal Investigator |
| 21314550 | Background | 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. |
| 33326345 | Background | 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. |
| 32999476 | Background | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |