New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

Thyroid-Associated Ophthalmopathy Clinical Trial

Official title:

New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693808
• Other study ID #: 2015/1175
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2024
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid-Associated Ophthalmopathy

Intervention

Procedure:
• Autologous fat injection
Injection in one side with autologous fat and the other side with hyaluronic acid.
• Hyaluronic acid injection
Injection in one side with autologous fat and the other side with hyaluronic acid.

Locations

Country	Name	City	State
Norway	Department of Ophthalmology Haukeland University Hospital	Bergen	Hordaland

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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):973-98 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with satisfactory objective cosmetic and functional outcome	Evaluation of photographs (1 to 3/Normalized to disfiguring)	2 years
Secondary	Volume of injected substance measured by ultrasonography	ml	2 years
Secondary	Number and type of complications	Hematoma, infection, embolization.	2 years
Secondary	Number of reinjections	Number.	2 years
Secondary	Number of patients with satisfactory subjective cosmetic and functional	Patient reported perception of outcome (1 to 3/Normalized to disfiguring)	2 years