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临床试验/NCT02693808
NCT02693808已完成不适用

New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
Number of patients with satisfactory objective cosmetic and functional outcome

研究概览

简要总结

The purpose of this study is to determine whether injection of autologous fat or hyaluronic-acid injections in temporal region are effective in the treatment of temporal hollowing after lateral wall decompression in patients with thyroid eye disease.

详细描述

Grave's disease is one of the most common autoimmune diseases. Thyroid eye disease is affecting nearly 50% of patients with Grave's disease. Surgical treatment may address several of the manifestations, including the increased volume of the orbital contents. Decompression of the orbit can be achieved by removing the lateral orbital walls; "lateral wall decompression".

In a retrospective study at the Department of Ophthalmology, Haukeland University Hospital, about half of the patients had a disfiguring hollowing in the temporal region after lateral wall decompression. The patient reported outcome of the procedure is clearly an indication for further esthetic treatment. However, until now the treatment option for these patients have been limited, or simply neglected. The investigators have contacted over 40 patients with this complication that want treatment.

In this project the investigators will treat bilateral hollowing with injection of autologous fat in one temporal region and hyaluronic-acid injections on the opposite side. Participants with unilateral hollowing will be randomized to one of the treatment options. Outcomes will be evaluated by clinical examination, photographs and ultrasound volume measurement at 6, 12, 18 and 24 months postoperatively. The participants will be retreated at these follow up intervals if necessary.

The project will be an interventional, prospective follow-up study and is approved by the regional ethics committee. The study will be the first of its kind to date as the investigators will be able to prospectively evaluate the effect of autologous fat injections to hyaluronic-acid injections in the same patient for the same condition.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Disfiguring temporal hollowing after lateral wall decompression.
  • The participant want treatment for temporal hollowing
  • Exclusion Critera:
  • The participant dont want treatment for temporal hollowing

排除标准

  • 未提供

结局指标

主要结局

Number of patients with satisfactory objective cosmetic and functional outcome

时间窗: 2 years

Evaluation of photographs (1 to 3/Normalized to disfiguring)

次要结局

  • Number of patients with satisfactory subjective cosmetic and functional(2 years)
  • Volume of injected substance measured by ultrasonography(2 years)
  • Number and type of complications(2 years)
  • Number of reinjections(2 years)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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