Department of Ophthalmology Haukeland University Hospital
Bergen, Hordaland, 5021, Norway
NCT Number: NCT02693808
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Bergen, Hordaland, 5021, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion Critera:
Injection in one side with autologous fat and the other side with hyaluronic acid.
Injection in one side with autologous fat and the other side with hyaluronic acid.
Time frame: 2 years
Evaluation of photographs (1 to 3/Normalized to disfiguring)
Time frame: 2 years
ml
Time frame: 2 years
Hematoma, infection, embolization.
Time frame: 2 years
Number.
Time frame: 2 years
Patient reported perception of outcome (1 to 3/Normalized to disfiguring)
Haukeland University Hospital
Other
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