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

Not Applicable

Not yet recruiting

• Conditions: Children With Torticollis
• Interventions: Diagnostic Test: Tilted Gaze Target Tast; Diagnostic Test: Conventional Examination Methods

• Registration Number: NCT05882552
• Lead Sponsor: Tianjin Eye Hospital

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-21
• Study First Posted: 2023-05-31
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09
• Study Start: 2023-06-15
• Primary Completion: 2024-06-15
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tilted Gaze Target Test+Conventional Examinations	Tilted Gaze Target Tast	Tilted gaze target test is before conventional examination
Tilted Gaze Target Test+Conventional Examinations	Conventional Examination Methods	Tilted gaze target test is before conventional examination
Conventional Examinations +Tilted Gaze Target Test	Conventional Examination Methods	Conventional examination is before tilted gaze target test
Conventional Examinations +Tilted Gaze Target Test	Tilted Gaze Target Tast	Conventional examination is before tilted gaze target test

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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