Clinical trial NCT02693808: New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression
Official title: New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid-Associated Ophthalmopathy
Keywords: Temporal hollowing
Lateral orbital wall decompression
Thyroid eye disease
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with satisfactory objective cosmetic and functional outcome
timeFrame: 2 years
Secondary outcomes:
measure: Volume of injected substance measured by ultrasonography
timeFrame: 2 years
measure: Number and type of complications
timeFrame: 2 years
measure: Number of reinjections
timeFrame: 2 years
measure: Number of patients with satisfactory subjective cosmetic and functional
timeFrame: 2 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Ophthalmology Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Eyvind Rødahl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNichols CH, Hatef DA, Cole P, Hollier LH, Thornton JF. Contemporary techniques for the correction of temporal hollowing: augmentation temporoplasty with the classic dermal fat graft. J Craniofac Surg. 2012 May;23(3):e234-8. doi: 10.1097/SCS.0b013e31824de5b8.
citation: Ueland HO, Nilsen RM, Rodahl E, Jensen SA. Hyaluronic acid is superior to autologous fat for treatment of temporal hollowing after lateral orbital wall decompression: A prospective interventional trial. J Plast Reconstr Aesthet Surg. 2019 Jun;72(6):973-981. doi: 10.1016/j.bjps.2018.12.031. Epub 2018 Dec 14.