Thyroid Associated OrbitopathyBOD-VASCNCT07393230
Changes in Orbital Macrovascular and Intraocular Microvascular Blood Flow After Orbital Decompression Surgery in Patients With Thyroid Eye Disease
A study testing Balanced Orbital Decompression Surgery in people with Thyroid Associated Orbitopathy, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Associated Orbitopathy
- What is being tested?
- Balanced Orbital Decompression Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2023to 25 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- History of systemic vasculitis or other vascular diseases
- Diabetes mellitus or systemic hypertension
- Use of systemic immunosuppressive therapy
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine, Department of Ophthalmology
Istanbul, Pendik, 34899
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Thyroid Associated Orbitopathy
- Being tested
- Balanced Orbital Decompression Surgery
- Keywords
- Thyroid-Associated Orbitopathy, Balanced Orbital Decompression, Orbital Blood Flow, Retinal and Choroidal Microcirculation, OCT Angiography, Doppler Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced Orbital Decompression SurgeryProcedure or surgery
Also called Combined medial and lateral orbital wall decompression with orbital fat excision
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Balanced Orbital Decompression Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start4 Apr 2023
- Primary completion30 Apr 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Associated OrbitopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Göğüş Çamlı, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393230
- Sponsor's protocol ID
- 09.2023.423
- Other IDs
- 09.2023.423
- Acronym
- BOD-VASC
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07393230
- Acronym / sponsor ID
- BOD-VASC / 09.2023.423
- Conditions
- Thyroid Associated Orbitopathy
- Keywords
- Thyroid-Associated Orbitopathy, Balanced Orbital Decompression, Orbital Blood Flow, Retinal and Choroidal Microcirculation, OCT Angiography, Doppler Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balanced Orbital Decompression Surgery | Experimental | Procedure: Balanced Orbital Decompression SurgeryParticipants in this arm undergo balanced orbital decompression surgery performed for inactive thyroid-associated orbitopathy, with preoperative and postoperative clinical and vascular assessments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced Orbital Decompression SurgeryAlso: Combined medial and lateral orbital wall decompression with orbital fat excisionBalanced 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. | Procedure or surgery | Balanced Orbital Decompression Surgery |
Primary outcome
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.
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.
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.
4 secondary outcomes
Change in superficial capillary plexus vessel density
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in deep capillary plexus vessel density
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in choriocapillaris vessel density
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Change in choroidal vascularity index
Time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Thyroid Associated Orbitopathy
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An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab
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Active, not recruitingPhase 3
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
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An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
Thyroid Eye Disease
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Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced Orbital Decompression Surgery in people with Thyroid Associated Orbitopathy, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ophthalmic artery flow velocities (time frame: Baseline and postoperative follow-up visits at 1, 3, and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.