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
About this trial
This is an interventional treatment trial for Strabismus, Mechanical
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
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
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
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Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy
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