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Completed

NCT Number: NCT02693808

New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous fat injection

Procedure

Injection in one side with autologous fat and the other side with hyaluronic acid.

Hyaluronic acid injection

Procedure

Injection in one side with autologous fat and the other side with hyaluronic acid.

Primary outcomes

  1. Number of patients with satisfactory objective cosmetic and functional outcome

    Time frame: 2 years

    Evaluation of photographs (1 to 3/Normalized to disfiguring)

Secondary outcomes

  1. Volume of injected substance measured by ultrasonography

    Time frame: 2 years

    ml

  2. Number and type of complications

    Time frame: 2 years

    Hematoma, infection, embolization.

  3. Number of reinjections

    Time frame: 2 years

    Number.

  4. Number of patients with satisfactory subjective cosmetic and functional

    Time frame: 2 years

    Patient reported perception of outcome (1 to 3/Normalized to disfiguring)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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