Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

Graves Ophthalmopathy Clinical Trial

Official title:

The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04927468
• Other study ID #: yanghs20210607
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Strabismus

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