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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Associated Ophthalmopathy
• Intervention / Treatment: Procedure: combination of orbital compression surgery and strabismus surgery; Procedure: orbital compression

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hua sheng Yang, M.D,PHD; Phone Number: +8620-87331539; Email: yanghs64@162.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: combination of orbital compression and strabismus surgery; orbital compression and strabismus surgery are performed at the same time	Procedure: combination of orbital compression surgery and strabismus surgery; combination of orbital compression surgery and strabismus surgery at the same time
ACTIVE_COMPARATOR: perform strabismus surgery after orbital compression; Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.	Procedure: orbital compression; orbital compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
strabismus status	angle of deviation including up-gaze, down-gaze ,left and right-gaze	6 weeks after surgery
strabismus status	angle of deviation including up-gaze, down-gaze ,left and right-gaze	6 months after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (ACTUAL): June 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Cranial Nerve Diseases; Ocular Motility Disorders; Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases; Strabismus
• Other Study ID Numbers: yanghs20210106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No