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临床试验/NCT07393230
NCT07393230已完成不适用

Evaluation of the Effect of Bilateral Balanced Orbital Decompression on Orbital, Retinal, and Choroidal Macro and Microvascular Blood Flow Parameters in Thyroid-Associated Orbitopathy

Marmara University Pendik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年4月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Change in ophthalmic artery flow velocities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Balanced Orbital Decompression Surgery (Procedure)

结局指标

主要结局

Change in ophthalmic artery flow velocities

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burçin Göğüş Çamlı

Ophthalmologist, Department of Ophthalmology, Marmara University School of Medicine

Marmara University Pendik Training and Research Hospital

研究点 (1)

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