Status:
COMPLETED
Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Graves Ophthalmopathy
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 gr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03278964
Start Date
February 5 2015
End Date
January 31 2019
Last Update
August 13 2019
Active Locations (1)
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1
University of Sao Paulo General Hospital
São Paulo, Brazil, 05403000