OCT Angiography Drived Alterations in Thyroid-associated Orbitopathy

NCT07341347 | Completed

• 1 other identifier: R1-11 819/2024.
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Thyroid Associated Orbitopathy

Keywords

cross-sectional

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with TED followed at Department of Ophthalmology, University Hospital Osijek, Department of Ophthalmology, Croatia.

You may qualify if:

• adult patients (≥18 years) of both sexes with a confirmed diagnosis of TAO treated at University Hospital Osijek.

You may not qualify if:

• 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

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

University Hospital Osijek

Osijek, 31000, Croatia

Location

Related Publications (4)

• 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.

  PMID: 31859550 BACKGROUND

• Yu 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.

  PMID: 33081749 BACKGROUND

• Ye 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.

  PMID: 30048168 BACKGROUND

• Wu 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.

  PMID: 40187512 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 14, 2026
• Study Start: December 9, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 30, 2025
• Last Updated: January 14, 2026

Record last verified: 2025-12

Locations

CR (1)