NCT02693808|Completed
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Sponsor study identifier
interventional
29
1 country
1
Study Start
November 2015
Actual (reported)Primary Completion
January 2018
Actual (reported)Study Completion
May 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Actual (reported)December 4, 2015
Actual (reported)February 29, 2016
Actual (reported)January 2018
Actual (reported)May 2018
Actual (reported)Number of patients with satisfactory objective cosmetic and functional outcome
Evaluation of photographs (1 to 3/Normalized to disfiguring)
2 years
Volume of injected substance measured by ultrasonography
2 years
Number and type of complications
2 years
Number of reinjections
2 years
Number of patients with satisfactory subjective cosmetic and functional
2 years
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.
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.
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.
Department of Ophthalmology Haukeland University Hospital
Bergen, Hordaland, 5021, Norway
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.
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.
Eyvind Rødahl, MD PhD
University of Bergen
29 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2015
First Posted
February 29, 2016
Study Start
November 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 2018
Actual (reported)Study Completion
May 2018
Actual (reported)Last Updated
March 1, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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