Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Children With Torticollis
• Intervention / Treatment: Diagnostic test: Tilted Gaze Target Tast; Diagnostic test: Conventional Examination Methods

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Li, M.D.; Phone Number: +86(22)27313336; Email: 15942046916@163.com
• Study Contact Backup: Name: Yatu Guo, Ph.D; Phone Number: +86(22)27313336; Email: yatuguo@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tilted Gaze Target Test+Conventional Examinations; Tilted gaze target test is before conventional examination	Diagnostic test: Tilted 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 test: Conventional 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.
Active Comparator: Conventional Examinations +Tilted Gaze Target Test; Conventional examination is before tilted gaze target test	Diagnostic test: Tilted 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 test: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Study Chair: Wei Zhang, Ph.D, Tianjin Eye Hospital; Study Director: Xiaotong Li, M.D., Tianjin Eye Hospital; Principal Investigator: Tiange Liu, MA.Sc, Nankai University; Principal Investigator: Zhen Li, MA.Sc, Nankai University

Publications and helpful links

General Publications

• McLean JM. Direct Surgery of Underacting Oblique Muscles. Trans Am Ophthalmol Soc. 1948;46:633-51. No abstract available.
• PARKS MM. Isolated cyclovertical muscle palsy. AMA Arch Ophthalmol. 1958 Dec;60(6):1027-35. doi: 10.1001/archopht.1958.00940081047008. No abstract available.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: strabismus; diagnosis; tilted gaze; superior oblique muscle palsy; projection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Dyskinesias; Dystonia; Torticollis
• Other Study ID Numbers: 2023018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No