University of Sao Paulo General Hospital
São Paulo, 05403000, Brazil
NCT Number: NCT03278964
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
São Paulo, 05403000, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Before orbital decompression and 1, 3 and 6 months after surgery
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Time frame: Before orbital decompression and 6 months after surgery
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
Time frame: Before orbital decompression and 1, 3 and 6 months after surgery
Evaluation by Gorman's Diplopia Table
Time frame: Before orbital decompression and 6 months after surgery
Using digital photography, Photoshop and Image J, ductions and versions will be analyzed
Time frame: Before orbital decompression and 6 months after surgery
Measure by orbital computerized tomography images
Time frame: Before orbital decompression and 6 months after surgery
Assessed by Lysozyme Green, Break-up time, Schirmer I test
Time frame: Before orbital decompression and 6 months after surgery
GO-QoL form
University of Sao Paulo General Hospital
Other
Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
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