CompletedNot Applicable

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

Turkey (Türkiye)15 participantsStarted 2023-04-04

Plain-language 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. 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in ophthalmic artery flow velocities

Timeframe: Baseline and postoperative follow-up visits at 1, 3, and 6 months

Change in central retinal artery flow velocities

Timeframe: Baseline and postoperative follow-up visits at 1, 3, and 6 months

Change in superior ophthalmic vein diameter

Timeframe: Baseline and postoperative follow-up visits at 1, 3, and 6 months

Trial details

NCT IDNCT07393230

SponsorMarmara University Pendik Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Thyroid Associated Orbitopathy trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.