The Accuracy of Applying the Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- The accuracy of test in predicting the degree of improvement in head position after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The accuracy of test in predicting the degree of improvement in head position after surgery
时间窗: 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.
次要结局
- 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)
- 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)