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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04927468
Other study ID # yanghs20210607
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date July 1, 2023

Study information

Verified date June 2021
Source Sun Yat-sen University
Contact Yang Huasheng
Phone +00862087331539
Email yanghs64@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy


Description:

To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
supramaximal rectus recession
inferior rectus recession is 10mm,medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus
normal rectus recession
inferior rectus recession is 7mm,medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative deviations Postoperative deviations in the primary position were measured in prism diopters 6 weeks
Primary Postoperative deviations Postoperative deviations in the primary position were measured in prism diopters 3 months
Primary Postoperative deviations Postoperative deviations in the primary position were measured in prism diopters 6 months
Secondary binocular single vision measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore. 6 weeks
Secondary binocular single vision measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore. 3 months
Secondary binocular single vision measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore. 6 months
Secondary stereoacuity measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis. 6 weeks
Secondary stereoacuity measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis. 3 months
Secondary stereoacuity measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis. 6 months
Secondary ocular motility evaluate the ocular motility with fixed visual field examination ,scaled from -4 to +4 6 weeks
Secondary ocular motility evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4 3 months
Secondary ocular motility evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4 6 months
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