New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

Conditions
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Thyroid-Associated Ophthalmopathy

Intervention / Treatment
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* Procedure: Autologous fat injection
* Procedure: Hyaluronic acid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disfiguring temporal hollowing after lateral wall decompression. The participant want treatment for temporal hollowing Exclusion Critera: The participant dont want treatment for temporal hollowing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous fat injection<br>Patients have undergone lateral orbital wall decompression on both sides. Temporal hollowing after surgery will be treated with injection on one side with autologous fat and the other side with long-lasting hyaluronic acid. | Procedure: Autologous fat injection<br>* Injection in one side with autologous fat and the other side with hyaluronic acid.<br>Procedure: Hyaluronic acid injection<br>* Injection in one side with autologous fat and the other side with hyaluronic acid.<br>|
| Active Comparator: Hyaluronic acid injection<br>Patients have undergone lateral orbital wall decompression on both sides. Temporal hollowing after surgery will be treated with injection on one side with autologous fat and the other side with long-lasting hyaluronic acid. | Procedure: Autologous fat injection<br>* Injection in one side with autologous fat and the other side with hyaluronic acid.<br>Procedure: Hyaluronic acid injection<br>* Injection in one side with autologous fat and the other side with hyaluronic acid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with satisfactory objective cosmetic and functional outcome | Evaluation of photographs (1 to 3/Normalized to disfiguring) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of injected substance measured by ultrasonography | ml | 2 years | 
| Number and type of complications | Hematoma, infection, embolization. | 2 years | 
| Number of reinjections | Number. | 2 years | 
| Number of patients with satisfactory subjective cosmetic and functional | Patient reported perception of outcome (1 to 3/Normalized to disfiguring) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporal hollowing, Lateral orbital wall decompression, Thyroid eye disease