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Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

Primary Purpose

Strabismus, Mechanical, Graves Ophthalmopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
supramaximal rectus recession
normal rectus recession
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strabismus, Mechanical

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Grave's ophthalmopathy
  • angle of deviation more than 20°
  • clinically and biochemically euthyroid for at least 3 months;
  • a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction
  • monocular and mainly single extraocular muscle restricted motility

Exclusion Criteria:

  • Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid
  • best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    supramaximal rectus recession

    normal rectus recession

    Arm Description

    supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy

    normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy

    Outcomes

    Primary Outcome Measures

    Postoperative deviations
    Postoperative deviations in the primary position were measured in prism diopters
    Postoperative deviations
    Postoperative deviations in the primary position were measured in prism diopters
    Postoperative deviations
    Postoperative deviations in the primary position were measured in prism diopters

    Secondary Outcome Measures

    binocular single vision
    measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
    binocular single vision
    measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
    binocular single vision
    measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
    stereoacuity
    measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
    stereoacuity
    measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
    stereoacuity
    measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
    ocular motility
    evaluate the ocular motility with fixed visual field examination ,scaled from -4 to +4
    ocular motility
    evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4
    ocular motility
    evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4

    Full Information

    First Posted
    June 8, 2021
    Last Updated
    June 15, 2021
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04927468
    Brief Title
    Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy
    Official Title
    The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy
    Detailed Description
    To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Strabismus, Mechanical, Graves Ophthalmopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    supramaximal rectus recession
    Arm Type
    Experimental
    Arm Description
    supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy
    Arm Title
    normal rectus recession
    Arm Type
    Active Comparator
    Arm Description
    normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy
    Intervention Type
    Procedure
    Intervention Name(s)
    supramaximal rectus recession
    Intervention Description
    inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus
    Intervention Type
    Procedure
    Intervention Name(s)
    normal rectus recession
    Intervention Description
    inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus
    Primary Outcome Measure Information:
    Title
    Postoperative deviations
    Description
    Postoperative deviations in the primary position were measured in prism diopters
    Time Frame
    6 weeks
    Title
    Postoperative deviations
    Description
    Postoperative deviations in the primary position were measured in prism diopters
    Time Frame
    3 months
    Title
    Postoperative deviations
    Description
    Postoperative deviations in the primary position were measured in prism diopters
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    binocular single vision
    Description
    measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
    Time Frame
    6 weeks
    Title
    binocular single vision
    Description
    measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
    Time Frame
    3 months
    Title
    binocular single vision
    Description
    measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
    Time Frame
    6 months
    Title
    stereoacuity
    Description
    measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
    Time Frame
    6 weeks
    Title
    stereoacuity
    Description
    measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
    Time Frame
    3 months
    Title
    stereoacuity
    Description
    measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
    Time Frame
    6 months
    Title
    ocular motility
    Description
    evaluate the ocular motility with fixed visual field examination ,scaled from -4 to +4
    Time Frame
    6 weeks
    Title
    ocular motility
    Description
    evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4
    Time Frame
    3 months
    Title
    ocular motility
    Description
    evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Grave's ophthalmopathy angle of deviation more than 20° clinically and biochemically euthyroid for at least 3 months; a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction monocular and mainly single extraocular muscle restricted motility Exclusion Criteria: Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Huasheng
    Phone
    +00862087331539
    Email
    yanghs64@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

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