An interventional study of Orbital decompression in Graves Ophthalmopathy, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's enrollment of 42 is below the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique.
Procedure: Orbital decompression
Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique.
Procedure: Orbital decompression
Change in Ocular Motility status
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Time frame: Before orbital decompression and 1, 3 and 6 months after surgery
Exophthalmos
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
Time frame: Before orbital decompression and 6 months after surgery
Diplopia
Evaluation by Gorman's Diplopia Table
Time frame: 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
Time frame: Before orbital decompression and 6 months after surgery
Volume of the extraocular muscles
Measure by orbital computerized tomography images
Time frame: Before orbital decompression and 6 months after surgery
Ocular surface evaluation
Assessed by Lysozyme Green, Break-up time, Schirmer I test
Time frame: Before orbital decompression and 6 months after surgery
Quality of life questionary Quality of life questionary
GO-QoL form
Time frame: Before orbital decompression and 6 months after surgery
Plan to share: Undecided
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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