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

NCT07393230 | Completed

• 1 other identifier: 09.2023.423
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Associated Orbitopathy

Keywords

Thyroid-Associated Orbitopathy; Balanced Orbital Decompression; Orbital Blood Flow; Retinal and Choroidal Microcirculation; OCT Angiography; Doppler Ultrasonography

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (4)

• Change in superficial capillary plexus vessel density

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

• Change in deep capillary plexus vessel density

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

• Change in choriocapillaris vessel density

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

• Change in choroidal vascularity index

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

Study Arms (1)

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.

Procedure: Balanced Orbital Decompression Surgery

Interventions

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.

Also known as: Combined medial and lateral orbital wall decompression with orbital fat excision

Balanced Orbital Decompression Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University School of Medicine, Department of Ophthalmology

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, Department of Ophthalmology, Marmara University School of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: April 4, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 25, 2024
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)