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

Primary Purpose

Children With Torticollis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tilted Gaze Target Tast
Conventional Examination Methods
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Children With Torticollis focused on measuring tilted gaze, superior oblique muscle palsy, strabismus, diagnosis, projection

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tilted Gaze Target Test+Conventional Examinations

    Conventional Examinations +Tilted Gaze Target Test

    Arm Description

    Tilted gaze target test is before conventional examination

    Conventional examination is before tilted gaze target test

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    May 6, 2023
    Last Updated
    June 8, 2023
    Sponsor
    Tianjin Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05882552
    Brief Title
    Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
    Official Title
    The Accuracy of Applying the Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    June 15, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Eye Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Children With Torticollis
    Keywords
    tilted gaze, superior oblique muscle palsy, strabismus, diagnosis, projection

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    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.
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tilted Gaze Target Test+Conventional Examinations
    Arm Type
    Experimental
    Arm Description
    Tilted gaze target test is before conventional examination
    Arm Title
    Conventional Examinations +Tilted Gaze Target Test
    Arm Type
    Active Comparator
    Arm Description
    Conventional examination is before tilted gaze target test
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Tilted Gaze Target Tast
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Conventional Examination Methods
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The accuracy of test in predicting the degree of improvement in head position after surgery
    Description
    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.
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    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
    Description
    Positive predictive value= (True Positives / (True Positives + False Positives)) * 100
    Time Frame
    1Week
    Title
    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
    Description
    Negative predictive value =(True Negatives / (True Negatives + False Negatives)) * 100
    Time Frame
    1Week
    Other Pre-specified Outcome Measures:
    Title
    The correlation between tilted gaze target test and Bielschowsky's head tilt test
    Description
    Pearson correlation and paired sample difference analyses were conducted to tilted gaze target test and Bielschowsky's head tilt test results
    Time Frame
    6 Months
    Title
    The correlation between the tilt angle and the degree of vertical and rotational strabismus
    Description
    Pearson correlation and paired sample difference analyses were conducted to the correlation between the tilt angle and the degree of vertical and rotational strabismus
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaotong Li, M.D.
    Phone
    +86(22)27313336
    Email
    15942046916@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yatu Guo, Ph.D
    Phone
    +86(22)27313336
    Email
    yatuguo@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei Zhang, Ph.D
    Organizational Affiliation
    Tianjin Eye Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Xiaotong Li, M.D.
    Organizational Affiliation
    Tianjin Eye Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Tiange Liu, MA.Sc
    Organizational Affiliation
    Nankai University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Zhen Li, MA.Sc
    Organizational Affiliation
    Nankai University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16693495
    Citation
    McLean JM. Direct Surgery of Underacting Oblique Muscles. Trans Am Ophthalmol Soc. 1948;46:633-51. No abstract available.
    Results Reference
    background
    PubMed Identifier
    13593934
    Citation
    PARKS MM. Isolated cyclovertical muscle palsy. AMA Arch Ophthalmol. 1958 Dec;60(6):1027-35. doi: 10.1001/archopht.1958.00940081047008. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21314550
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33326345
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32999476
    Citation
    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.
    Results Reference
    background

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

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