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

Tianjin Eye Hospital

Status: Not yet enrolling

Conditions: Children With Torticollis

Treatments: Diagnostic Test: Tilted Gaze Target Tast; Diagnostic Test: Conventional Examination Methods

Study type: Interventional

Funder types: Other

Identifiers

NCT05882552

2023018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Tilted Gaze Target Test+Conventional Examinations

Experimental group

Description:

Tilted gaze target test is before conventional examination

Treatment:

Diagnostic Test: Tilted Gaze Target Tast

Diagnostic Test: Conventional Examination Methods

Conventional Examinations +Tilted Gaze Target Test

Active Comparator group

Description:

Conventional examination is before tilted gaze target test

Treatment:

Diagnostic Test: Tilted Gaze Target Tast

Diagnostic Test: Conventional Examination Methods