An interventional study of Balanced Orbital Decompression Surgery in Thyroid Associated Orbitopathy, sponsored by Marmara University Pendik Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Marmara University Pendik Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
Marmara University Pendik Training and Research Hospital is the lead sponsor of 32 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm undergo balanced orbital decompression surgery performed for inactive thyroid-associated orbitopathy, with preoperative and postoperative clinical and vascular assessments.
Procedure: Balanced Orbital Decompression Surgery
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.
Also known as: Combined medial and lateral orbital wall decompression with orbital fat excision
Change in ophthalmic artery flow velocities
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 central retinal artery flow velocities
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
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 superficial capillary plexus vessel density
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 deep capillary plexus vessel density
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 choriocapillaris vessel density
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
Change in choroidal vascularity index (unitless), assessed by optical coherence tomography before and after surgery.
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Plan to share: No
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Marmara University Pendik Training and Research Hospital