Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy

Study Overview
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Brief Summary
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Randomized prospective clinical trial, aiming to compare two techniques of orbital decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months will be divided in two groups; one group will be submitted to orbital decompression by antro-ethmoidal technique; the other group will be submitted to orbital decompression by lateral wall technique. Patients will be followed up for a period of 6 months after the surgery, and will be evaluated about the effect of orbital decompression on ocular motility, proptosis, ocular surface and quality of life.

Detailed Description
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Graves' orbitopathy is the most relevant non-thyroid manifestation of Graves' disease. Its clinical status varies from subclinical to severe deformities. Clinical features include palpebral retraction, exophthalmos, restrictive strabismus, chemosis, ocular surface lesions and optic neuropathy. There are two stages of the disease. There is an active phase in which the inflammatory process is present and the orbital changes evolve. The inactive phase comprises a stable clinical picture regarding the sequelae of the active phase. Orbital decompression surgery is the main treatment procedure for this inactive phase for functional and cosmetic rehabilitation purposes. In the last decades, great advances in the techniques and indication of this surgery have been observed. However, a consensus about the ideal technique does not yet exist. The most commonly used techniques are antro-ethmoidal decompression and lateral wall decompression alone or associated with other walls. The present study will be based on patients with Graves' orbitopathy diagnosis for at least 2 years and who are already in the inactive phase for at least 6 months. There are no prospective studies comparing the 2 main orbital decompression techniques through a detailed analysis of surgical outcomes from computed tomography images, digital photographic images and ocular motility examination. These informations will be collected in the preoperative and postoperative periods. The investigators will evaluate the decompressive potential of each technique calculated by the tomographic images. Participants will be followed up for a period of 6 months after the surgical procedure and the effect of decompression on ocular motility, ocular bulb positioning, ocular surface, vertical palpebral fissure, and the patient's quality of life will also be analyzed. The findings of this work will bring important contribution to the improvement of this surgical procedure of great relevance in the rehabilitation of patients with Graves' orbitopathy.

Official Title
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Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy

Conditions
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Graves Ophthalmopathy

Intervention / Treatment
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* Procedure: Orbital decompression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Graves orbitopathy for at least 2 years Clinical Activity Score (CAS) < 4 for at least 6 months Agreement with the Informed Consent Form, which will be signed during the selection visit Ability to come to periodic evaluations for 6 months after the orbital decompression Absence of ocular abnormalities such as degenerative myopia, microphthalmia or anophthalmic cavity Absence of orbital abnormalities such as previous fractures or congenital defects Good collaboration for the exams Euthyroidism Exophthalmus ≥ 20 mm in Hertel's exophthalmometry Preoperative clinical evaluation indicating absence of contraindications for a surgical procedure Exclusion Criteria: Myasthenia gravis Pregnancy Previous orbital, strabismus or eyelid surgery Other abnormal eye conditions or symptoms that make it impossible to admit the patient to the study, according to the clinical judgment of the investigator.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with Graves orbitopathy will be randomly divided in two groups. One group will be submmited to orbital decompression by antro-ethmoidal technique. The other group will be treated by lateral wall technique.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antro-ethmoidal technique<br>Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique. | Procedure: Orbital decompression<br> <br> |
| Experimental: Lateral wall technique<br>Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique. | Procedure: Orbital decompression<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Motility status | Measure by prism and cover, to assess strabismus in the nine positions of gaze | Before orbital decompression and 1, 3 and 6 months after surgery | 
| Exophthalmos | Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography | Before orbital decompression and 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diplopia | Evaluation by Gorman's Diplopia Table | Before orbital decompression and 1, 3 and 6 months after surgery | 
| Digital photography evaluation | Using digital photography, Photoshop and Image J, ductions and versions will be analyzed | Before orbital decompression and 6 months after surgery | 
| Volume of the extraocular muscles | Measure by orbital computerized tomography images | Before orbital decompression and 6 months after surgery | 
| Ocular surface evaluation | Assessed by Lysozyme Green, Break-up time, Schirmer I test | Before orbital decompression and 6 months after surgery | 
| Quality of life questionary Quality of life questionary | GO-QoL form | Before orbital decompression and 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graves Disease, Orbital decompression, Graves Orbitopathy, Exophthalmos, Diplopia, Restrictive Strabismus