Thyroid-Associated Ophthalmopathy
Conditions
Keywords
Temporal hollowing, Lateral orbital wall decompression, Thyroid eye disease
Brief summary
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
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.
Interventions
PROCEDUREAutologous fat injection
Injection in one side with autologous fat and the other side with hyaluronic acid.
PROCEDUREHyaluronic acid injection
Injection in one side with autologous fat and the other side with hyaluronic acid.
Sponsors
Haukeland University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with satisfactory objective cosmetic and functional outcome | 2 years | Evaluation of photographs (1 to 3/Normalized to disfiguring) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of injected substance measured by ultrasonography | 2 years | ml |
| Number and type of complications | 2 years | Hematoma, infection, embolization. |
| Number of reinjections | 2 years | Number. |
| Number of patients with satisfactory subjective cosmetic and functional | 2 years | Patient reported perception of outcome (1 to 3/Normalized to disfiguring) |
Countries
Norway
Outcome results
None listed