Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With… (NCT03278964) | Clinical Trial Compass
CompletedNot Applicable
Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
Brazil42 participantsStarted 2015-02-05
Plain-language 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 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Ocular Motility status
Timeframe: Before orbital decompression and 1, 3 and 6 months after surgery
2
Exophthalmos
Timeframe: Before orbital decompression and 6 months after surgery