Marmara University School of Medicine, Department of Ophthalmology
Istanbul, Pendik, 34899, Turkey (Türkiye)
NCT Number: NCT07393230
This study aims to evaluate the effects of balanced orbital decompression surgery in patients with inactive thyroid-associated orbitopathy. The study examines how the surgery influences blood flow in the orbit and microcirculation in the retina and choroid over time. Clinical findings, imaging results, and vascular changes before and after surgery will be analyzed to better understand the anatomical and functional outcomes of the procedure.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Istanbul, Pendik, 34899, Turkey (Türkiye)
Thyroid-associated orbitopathy (TAO) is an autoimmune condition that can lead to increased orbital tissue volume, proptosis, elevated intraocular pressure, and impaired venous outflow. In the inactive phase of the disease, balanced orbital decompression (BOD) is commonly performed to relieve orbital pressure and improve both anatomical and functional outcomes.
While the clinical benefits of orbital decompression are well established, its effects on orbital blood flow and intraocular microcirculation have not been sufficiently investigated, particularly over time. This study is designed to prospectively evaluate the impact of BOD on orbital macrovascular structures and retinal-choroidal microvascular networks in patients with inactive TAO.
Patients undergoing BOD for severe proptosis will be evaluated before surgery and at multiple postoperative follow-up visits. Assessments include clinical ophthalmologic examinations, intraocular pressure measurements, and imaging-based evaluation of orbital and intraocular circulation. Orbital macrovascular parameters will be assessed using Doppler ultrasonography, while retinal and choroidal microcirculation will be analyzed using optical coherence tomography angiography (OCTA).
The study aims to characterize time-dependent vascular changes following surgery and to explore the relationship between macrovascular and microvascular responses. By providing longitudinal data, this study seeks to improve understanding of how orbital decompression influences ocular perfusion and vascular regulation, contributing to a more comprehensive evaluation of surgical outcomes in inactive TAO.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Balanced orbital decompression is performed under general anesthesia using a combined medial and lateral orbital wall approach with orbital fat removal, aiming to reduce orbital pressure and improve orbital and ocular circulation in patients with inactive thyroid-associated orbitopathy.
Other names: Combined medial and lateral orbital wall decompression with orbital fat excision
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in peak systolic velocity and end-diastolic velocity of the ophthalmic artery, measured in cm/s, assessed by color Doppler ultrasonography before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in peak systolic velocity and end-diastolic velocity of the central retinal artery, measured in cm/s, assessed by color Doppler ultrasonography before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in superior ophthalmic vein diameter, measured in millimeters (mm), assessed by magnetic resonance imaging before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in vessel density of the superficial capillary plexus, expressed as a percentage (%), assessed by optical coherence tomography angiography before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in vessel density of the deep capillary plexus, expressed as a percentage (%), assessed by optical coherence tomography angiography before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in vessel density of the choriocapillaris, expressed as a percentage (%), assessed by optical coherence tomography angiography before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in choroidal vascularity index (unitless), assessed by optical coherence tomography before and after surgery.
Marmara University Pendik Training and Research Hospital
Other
Evaluation of the Effect of Bilateral Balanced Orbital Decompression on Orbital, Retinal, and Choroidal Macro and Microvascular Blood Flow Parameters in Thyroid-Associated Orbitopathy
Acronym: BOD-VASC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07341347
Thyroid Associated Orbitopathy
Osijek, Croatia
View Trial DetailsNCT05429450
Thyroid Associated Orbitopathy
Cairo, Egypt
View Trial DetailsNCT03131726
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Malmö, Sweden
View Trial Details