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NCT Number: NCT07393230

Changes in Orbital Macrovascular and Intraocular Microvascular Blood Flow After Orbital Decompression Surgery in Patients With Thyroid Eye Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine, Department of Ophthalmology

Istanbul, Pendik, 34899, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Diagnosis of inactive thyroid-associated orbitopathy
  • Presence of moderate-to-severe proptosis with indication for surgical orbital decompression
  • Planned to undergo balanced orbital decompression surgery
  • Ability to provide written informed consent
  • Adequate image quality for OCTA and Doppler ultrasonography assessments

Exclusion criteria

  • Active phase thyroid-associated orbitopathy
  • Thyroid dysfunction or systemic condition contraindicating general anesthesia
  • Proptosis due to causes other than TAO
  • History of orbital radiotherapy
  • Previous orbital or intraocular surgery
  • Presence of retinal or choroidal pathology affecting vascular measurements
  • History of systemic vasculitis or other vascular diseases
  • Diabetes mellitus or systemic hypertension
  • Use of systemic immunosuppressive therapy
  • Age under 18 years

Treatment and study plan

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.

Other names: Combined medial and lateral orbital wall decompression with orbital fat excision

Primary outcomes

  1. Change in ophthalmic artery flow velocities

    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.

  2. Change in central retinal artery flow velocities

    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.

  3. Change in superior ophthalmic vein diameter

    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.

Secondary outcomes

  1. Change in superficial capillary plexus vessel density

    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.

  2. Change in deep capillary plexus vessel density

    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.

  3. Change in choriocapillaris vessel density

    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.

  4. Change in choroidal vascularity index

    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.

Sponsors and collaborators

Lead sponsor

Marmara University Pendik Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

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.

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