Thyroid Associated Ophthalmopathy
Conditions
Brief 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
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.
Interventions
PROCEDUREcombination of orbital compression surgery and strabismus surgery
combination of orbital compression surgery and strabismus surgery at the same time
PROCEDUREorbital compression
orbital compression
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) . | 6 weeks after surgery | 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. |
| quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) . | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| strabismus status | 6 weeks after surgery | angle of deviation including up-gaze, down-gaze ,left and right-gaze |
Countries
China
Contacts
Primary ContactHua sheng Yang, M.D,PHD
Outcome results
None listed