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| ID | Type | Description | Link |
|---|---|---|---|
| 09.2023.423 | Registry Identifier | Marmara University School of Medicine Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced Orbital Decompression Surgery | Experimental | Participants in this arm undergo balanced orbital decompression surgery performed for inactive thyroid-associated orbitopathy, with preoperative and postoperative clinical and vascular assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced Orbital Decompression Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline and postoperative follow-up visits at 1, 3, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and postoperative follow-up visits at 1, 3, and 6 months |
| Change in deep capillary plexus vessel density |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University School of Medicine, Department of Ophthalmology | Istanbul | Pendik | 34899 | Turkey (Türkiye) |
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This is a prospective, single-center, interventional study in which patients with inactive thyroid-associated orbitopathy undergo balanced orbital decompression surgery. Clinical, orbital macrovascular, and retinal-choroidal microvascular parameters are evaluated before surgery and at predefined postoperative follow-up visits.
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Change in vessel density of the deep capillary plexus, expressed as a percentage (%), assessed by optical coherence tomography angiography before and after surgery. |
| 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. | 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. | Baseline and postoperative follow-up visits at 1, 3, and 6 months |