Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy

Thyroid Associated Ophthalmopathy Clinical Trial

Official title:

The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04919694
• Other study ID #: yanghs20210106
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: Sun Yat-sen University
• Contact: Hua sheng Yang, M.D,PHD
• Phone: +8620-87331539
• Email: yanghs64[@]162.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether combination of orbital compression surgery with strabismus surgery is better than strabismus surgery after orbital compression surgery in the treatment of moderate-to-severe thyroid associated ophthalmopathy

Description:

This study will be a interventional case series. Patients with moderate-to-severe thyroid associated ophthalmopathy will be randomized to receive combination of orbital compression surgery with strabismus surgery or strabismus surgery after orbial compression surgery.Patients will be followed for 6 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• moderate-to-severe thyroid associate ophthalmopathy

• CAS=3 score

• monocular strabismus,deviation=20° or 35?

• stable thyroid function for at least 6 months, confirmed by an endocrinologist

Exclusion Criteria:

• any previous disease in the study eye.

• any previous systematic disease

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Strabismus
• Thyroid Associated Ophthalmopathy
• Thyroid Diseases

Intervention

Procedure:
• combination of orbital compression surgery and strabismus surgery
combination of orbital compression surgery and strabismus surgery at the same time
• orbital compression
orbital compression

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .	All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = [(raw score - 8)/16 9 100]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = [(raw score - *)/(2x*) x100] where * is the number of completed items.	6 weeks after surgery
Primary	quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) .	All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = [(raw score - 8)/16 9 100]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = [(raw score - *)/(2x*) x100] where * is the number of completed items.	6 months
Secondary	strabismus status	angle of deviation including up-gaze, down-gaze ,left and right-gaze	6 weeks after surgery
Secondary	strabismus status	angle of deviation including up-gaze, down-gaze ,left and right-gaze	6 months after surgery