Thyroid Associated OrbitopathyTAONCT07341347
OCT Angiography Drived Alterations in Thyroid-associated Orbitopathy
An observational study of Thyroid Associated Orbitopathy, run by Osijek University Hospital at 1 site in Croatia.
Trial summary
The aim of this observational study is to evaluate retinal microvascular alterations in patients with thyroid-associated orbitopathy (TAO) using optical coherence tomography angiography (OCTA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Associated Orbitopathy
- How many people
- 68 participants
- Where
- 1 siteCroatia
- Study dates
- 9 Dec 2024to 30 Jul 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with TED followed at Department of Ophthalmology, University Hospital Osijek, Department of Ophthalmology, Croatia.
Who may be able to join
- adult patients (≥18 years) of both sexes with a confirmed diagnosis of TAO treated at University Hospital Osijek.
Who cannot join
- anterior segment pathology (e.g., central keratopathy),
- primary open- or closed-angle glaucoma,
- posterior segment disorders (e.g., diabetic retinopathy, age-related macular degeneration, retinal vascular occlusion),
- previous ocular trauma or uveitis,
- refractive errors exceeding ±6.0 Diopter sphere or ±3.0 Diopter cylinder
- media opacities that compromised angio optical OCTA image quality,
- contraindication for orbital MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Morphological Orbital Changes on the Retinal Vascular Layers in Patients With Thyroid-associated Orbiopathy
The aim of this observational study is to evaluate retinal microvascular alterations in patients with thyroid-associated orbitopathy (TAO) using optical coherence tomography angiography (OCTA). The specific objectives are:
- To assess the impact of extraocular muscle (EOM) enlargement on vessel density in the superficial and deep retinal capillary plexuses in patients with TAO.
- To determine the effect of increased orbital fat volume on superficial and deep retinal vessel density in TAO.
- To evaluate the relationship between disease activity, as measured by the Clinical Activity Score (CAS), and retinal microvascular density in patients with TAO.
Read the detailed description
After obtaining written informed consent and confirming eligibility, all patients with TAO and controls underwent a detailed medical history review and ophthalmologic examination. Collected clinical data included age and sex. For patients with TAO collected data also oncluded duration of Graves' hyperthyroidism (GH) and orbitopathy (GO), as well as serum levels of thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), thyrotropin receptor antibodies (TRAb), and anti-thyroid peroxidase antibodies (anti-TPO). For all participants a comprehensive ophthalmologic assessment was performed, which included evaluation of the periocular region, ocular motility, pupillary reflexes, best-corrected visual acuity (BCVA), slit-lamp biomicroscopy, intraocular pressure (IOP) measurement using Goldmann applanation tonometry in primary and upward gaze, exophthalmometry with a Hertel device, and dilated fundus examination.
Disease activity in patientss with TAO was assessed using the Clinical Activity Score (CAS), following the European Group on Graves' Orbitopathy (EUGOGO) guidelines.
MRI images of orbit in TAO patients acquired using 1.5T and 3T scanners (Siemens Magnetom Avanto Fit 124 and Magnetom Skyra, Siemens Healthcare, Germany) during TAO evaluation were reviewed manually by an experienced radiologist using the PACS imaging software (Sectra 126 IDS7, Version 24.1, Linköping, Sweden). Measurements were performed on T1- and T2-weighted images in both coronal and axial planes.The maximum diameter of each of the four rectus muscles (medial, lateral, superior, and inferior) was measured at its thickest midpoint. Horizontal diameters of the medial and lateral rectus muscles were obtained on axial images, while vertical diameters of the superior and inferior rectus muscles were measured on coronal sections.
Exophthalmos was determined as the perpendicular distance between the anterior surface of the cornea and the line connecting both lateral orbital rims on the slice where the globe and optic nerve were most clearly visualized. Orbital fat thickness was measured as the maximum distance from the lateral border of the medial rectus muscle to the medial orbital wall. Based on radiological characteristics, patients with TAO were classified into three subtypes: fat-predominant, muscle-predominant, and mixed type.
Optical coherence tomography angiography (OCTA) was performed in all paticipants (patients with TAO and controls) using the OptoVue XR Avanti device equipped with the split-spectrum amplitude-decorrelation angiography (SSADA) algorithm (software version 2014.2.0.90), with the Angio Retina 6×6 mm protocol. Retinal vessel density was analyzed at two vascular levels-the superficial capillary plexus and the deep capillary plexus. Following the instrument's standardized protocol, the macula was divided into nine regions: a central foveal zone, parafoveal ring, and perifoveal ring, each subdivided into superior, inferior, nasal, and temporal quadrants. The foveal avascular zone was also measured.
- Conditions
- Thyroid Associated Orbitopathy
- Keywords
- cross-sectional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with TAO | The study cohort consisted of patients diagnosed with TAO of varying activity and duration. All subjects were Caucasian without other significant ocular comorbidities that could confound retinal microvascular measurements. Patients with TAO were classified based on MRI characteristics into three subgroups: fat-predominant, muscle-predominant, and mixed type. | |
| Control group | Participants without TAO or other significant ocular comorbidities were included. All subjects were Caucasian and were age- and gender-matched to the TAO patient group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel density (VD)
Vessel density reflects the proportion of perfused vasculature within a defined retinal area and serves as a quantitative marker of retinal microcirculation. VD was evaluated separately in the superficial capillary plexus and the deep capillary plexus across the whole image as well as within the foveal, parafoveal, and perifoveal regions. Changes in vessel density were used to characterize microvascular alterations associated with thyroid-associated orbitopathy compared to healthy patients and to explore their relationship with disease activity and orbital structural parameters in TAO patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start9 Dec 2024
- Primary completion15 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341347
- Sponsor's protocol ID
- R1-11 819/2024.
- Acronym
- TAO
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mihailovic N, Lahme L, Rosenberger F, Hirscheider M, Termuhlen J, Heiduschka P, Grenzebach U, Eter N, Alnawaiseh M. ALTERED RETINAL PERFUSION IN PATIENTS WITH INACTIVE GRAVES OPHTHALMOPATHY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Endocr Pract. 2020 Mar;26(3):312-317. doi: 10.4158/EP-2019-0328. Epub 2019 Dec 20.
PubMed 31859550Yu L, Jiao Q, Cheng Y, Zhu Y, Lin Z, Shen X. Evaluation of retinal and choroidal variations in thyroid-associated ophthalmopathy using optical coherence tomography angiography. BMC Ophthalmol. 2020 Oct 20;20(1):421. doi: 10.1186/s12886-020-01692-7.
PubMed 33081749Ye L, Zhou SS, Yang WL, Bao J, Jiang N, Min YL, Yuan Q, Tan G, Shen M, Shao Y. RETINAL MICROVASCULATURE ALTERATION IN ACTIVE THYROID-ASSOCIATED OPHTHALMOPATHY. Endocr Pract. 2018 Jul;24(7):658-667. doi: 10.4158/EP-2017-0229.
PubMed 30048168Wu H, Song Q, Zhang Y, Cheng R, Li Y, Su M, Zhang X, Sun X. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) for assessing thyroid-associated ophthalmopathy activity. Photodiagnosis Photodyn Ther. 2025 Jun;53:104578. doi: 10.1016/j.pdpdt.2025.104578. Epub 2025 Apr 3.
PubMed 40187512
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Morphological Orbital Changes on the Retinal Vascular Layers in Patients With Thyroid-associated Orbiopathy
- ClinicalTrials.gov ID
- NCT07341347
- Acronym / sponsor ID
- TAO / R1-11 819/2024.
- Conditions
- Thyroid Associated Orbitopathy
- Keywords
- cross-sectional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 14 Jan 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.
The aim of this observational study is to evaluate retinal microvascular alterations in patients with thyroid-associated orbitopathy (TAO) using optical coherence tomography angiography (OCTA). The specific objectives are:
- To assess the impact of extraocular muscle (EOM) enlargement on vessel density in the superficial and deep retinal capillary plexuses in patients with TAO.
- To determine the effect of increased orbital fat volume on superficial and deep retinal vessel density in TAO.
- To evaluate the relationship between disease activity, as measured by the Clinical Activity Score (CAS), and retinal microvascular density in patients with TAO.
Detailed description
After obtaining written informed consent and confirming eligibility, all patients with TAO and controls underwent a detailed medical history review and ophthalmologic examination. Collected clinical data included age and sex. For patients with TAO collected data also oncluded duration of Graves' hyperthyroidism (GH) and orbitopathy (GO), as well as serum levels of thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), thyrotropin receptor antibodies (TRAb), and anti-thyroid peroxidase antibodies (anti-TPO). For all participants a comprehensive ophthalmologic assessment was performed, which included evaluation of the periocular region, ocular motility, pupillary reflexes, best-corrected visual acuity (BCVA), slit-lamp biomicroscopy, intraocular pressure (IOP) measurement using Goldmann applanation tonometry in primary and upward gaze, exophthalmometry with a Hertel device, and dilated fundus examination.
Disease activity in patientss with TAO was assessed using the Clinical Activity Score (CAS), following the European Group on Graves' Orbitopathy (EUGOGO) guidelines.
MRI images of orbit in TAO patients acquired using 1.5T and 3T scanners (Siemens Magnetom Avanto Fit 124 and Magnetom Skyra, Siemens Healthcare, Germany) during TAO evaluation were reviewed manually by an experienced radiologist using the PACS imaging software (Sectra 126 IDS7, Version 24.1, Linköping, Sweden). Measurements were performed on T1- and T2-weighted images in both coronal and axial planes.The maximum diameter of each of the four rectus muscles (medial, lateral, superior, and inferior) was measured at its thickest midpoint. Horizontal diameters of the medial and lateral rectus muscles were obtained on axial images, while vertical diameters of the superior and inferior rectus muscles were measured on coronal sections.
Exophthalmos was determined as the perpendicular distance between the anterior surface of the cornea and the line connecting both lateral orbital rims on the slice where the globe and optic nerve were most clearly visualized. Orbital fat thickness was measured as the maximum distance from the lateral border of the medial rectus muscle to the medial orbital wall. Based on radiological characteristics, patients with TAO were classified into three subtypes: fat-predominant, muscle-predominant, and mixed type.
Optical coherence tomography angiography (OCTA) was performed in all paticipants (patients with TAO and controls) using the OptoVue XR Avanti device equipped with the split-spectrum amplitude-decorrelation angiography (SSADA) algorithm (software version 2014.2.0.90), with the Angio Retina 6×6 mm protocol. Retinal vessel density was analyzed at two vascular levels-the superficial capillary plexus and the deep capillary plexus. Following the instrument's standardized protocol, the macula was divided into nine regions: a central foveal zone, parafoveal ring, and perifoveal ring, each subdivided into superior, inferior, nasal, and temporal quadrants. The foveal avascular zone was also measured.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with TAO | – | –The study cohort consisted of patients diagnosed with TAO of varying activity and duration. All subjects were Caucasian without other significant ocular comorbidities that could confound retinal microvascular measurements. Patients with TAO were classified based on MRI characteristics into three subgroups: fat-predominant, muscle-predominant, and mixed type. |
| Control group | – | –Participants without TAO or other significant ocular comorbidities were included. All subjects were Caucasian and were age- and gender-matched to the TAO patient group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with TED followed at Department of Ophthalmology, University Hospital Osijek, Department of Ophthalmology, Croatia.
Key inclusion criteria (1 listed)
- adult patients (≥18 years) of both sexes with a confirmed diagnosis of TAO treated at University Hospital Osijek.
Key exclusion criteria (7 listed)
- anterior segment pathology (e.g., central keratopathy),
- primary open- or closed-angle glaucoma,
- posterior segment disorders (e.g., diabetic retinopathy, age-related macular degeneration, retinal vascular occlusion),
- previous ocular trauma or uveitis,
- refractive errors exceeding ±6.0 Diopter sphere or ±3.0 Diopter cylinder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal vessel density (VD)
Time frame: Baseline
Vessel density reflects the proportion of perfused vasculature within a defined retinal area and serves as a quantitative marker of retinal microcirculation. VD was evaluated separately in the superficial capillary plexus and the deep capillary plexus across the whole image as well as within the foveal, parafoveal, and perifoveal regions. Changes in vessel density were used to characterize microvascular alterations associated with thyroid-associated orbitopathy compared to healthy patients and to explore their relationship with disease activity and orbital structural parameters in TAO patients.
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 14 Jan 2026.
- Background: PubMed 31859550Mihailovic N, Lahme L, Rosenberger F, Hirscheider M, Termuhlen J, Heiduschka P, Grenzebach U, Eter N, Alnawaiseh M. ALTERED RETINAL PERFUSION IN PATIENTS WITH INACTIVE GRAVES OPHTHALMOPATHY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Endocr Pract. 2020 Mar;26(3):312-317. doi: 10.4158/EP-2019-0328. Epub 2019 Dec 20.
- Background: PubMed 33081749Yu L, Jiao Q, Cheng Y, Zhu Y, Lin Z, Shen X. Evaluation of retinal and choroidal variations in thyroid-associated ophthalmopathy using optical coherence tomography angiography. BMC Ophthalmol. 2020 Oct 20;20(1):421. doi: 10.1186/s12886-020-01692-7.
- Background: PubMed 30048168Ye L, Zhou SS, Yang WL, Bao J, Jiang N, Min YL, Yuan Q, Tan G, Shen M, Shao Y. RETINAL MICROVASCULATURE ALTERATION IN ACTIVE THYROID-ASSOCIATED OPHTHALMOPATHY. Endocr Pract. 2018 Jul;24(7):658-667. doi: 10.4158/EP-2017-0229.
- Background: PubMed 40187512Wu H, Song Q, Zhang Y, Cheng R, Li Y, Su M, Zhang X, Sun X. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) for assessing thyroid-associated ophthalmopathy activity. Photodiagnosis Photodyn Ther. 2025 Jun;53:104578. doi: 10.1016/j.pdpdt.2025.104578. Epub 2025 Apr 3.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Thyroid Associated Orbitopathy, run by Osijek University Hospital at 1 site in Croatia.
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 1 inclusion and 7 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 14 Jan 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 Croatia. 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?
Retinal vessel density (VD) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341347, which also lists 4 linked publications.
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 14 Jan 2026.