NCT04662190已完成不适用
Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.
Althaia Xarxa Assistencial Universitària de Manresa1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年7月5日最近更新:
适应症
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
- 12
- 试验地点
- 1
- 主要终点
- Exophthalmos
研究概览
简要总结
This is a multicentric, randomized, single-blinded clinical trial to evaluate the efficacy and safety of 3D printing for the planification and simulation of orbital decompression surgery for thyroid-associated orbitopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of inactive thyroid-associated orbitopathy requiring bilateral orbital decompression (moderate-severe in EUGOGO classification).
- •Volunteers older than 18 years old.
- •Ability to read.
- •Acceptation to participate and signature of informed consent.
排除标准
- •Younger than 18 years old.
- •Previous orbital surgery.
- •Any coexisting disease preventing follow-up.
研究组 & 干预措施
Control grup
Active Comparator
Conventional surgery.
干预措施: Standard surgery (Procedure)
Intervention group
Experimental
Surgery planned, simulated and guided by 3D printing.
干预措施: 3D printing model/guide. (Device)
结局指标
主要结局
Exophthalmos
时间窗: 6 months
Exophthalmos measured in millimeters
Intraoperative complications
时间窗: 6 months
Intraoperative complications
Postoperative complications
时间窗: 6 months
Postoperative complications
Diplopia
时间窗: 6 months
Diplopia correction
次要结局
未报告次要终点
研究者
Eduard Pedemonte-Sarrias
Ophthalmologist, MD, PhD
Althaia Xarxa Assistencial Universitària de Manresa
研究点 (1)
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