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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antro-ethmoidal technique | Active Comparator | Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique. |
|
| Lateral wall technique | Experimental | Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orbital decompression | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARIO L RIBEIRO MONTEIRO, PHD | University of Sao Paulo General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo General Hospital | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33852655 | Derived | Leite CA, Pereira TS, Chiang J, Moritz RB, Goncalves ACP, Monteiro MLR. Ocular motility changes after inferomedial wall and balanced medial plus lateral wall orbital decompression in Graves' orbitopathy: a randomized prospective comparative study. Clinics (Sao Paulo). 2021 Apr 9;76:e2592. doi: 10.6061/clinics/2021/e2592. eCollection 2021. | |
| 32832143 |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D004172 | Diplopia |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
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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.
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Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.
| 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 |
| Leite CA, Pereira TS, Chiang J, Pieroni Goncalves AC, Monteiro MLR. Evaluation of Ocular Versions in Graves' Orbitopathy: Correlation between the Qualitative Clinical Method and the Quantitative Photographic Method. J Ophthalmol. 2020 Jul 31;2020:9758153. doi: 10.1155/2020/9758153. eCollection 2020. |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |