New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

February 29, 2024 updated by: Haukeland University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Department of Ophthalmology Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Autologous fat injection
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.
Procedure: Autologous fat injection
Injection in one side with autologous fat and the other side with hyaluronic acid.
Procedure: Hyaluronic acid injection
Injection in one side with autologous fat and the other side with hyaluronic acid.
Active Comparator: Hyaluronic acid injection
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.
Procedure: Autologous fat injection
Injection in one side with autologous fat and the other side with hyaluronic acid.
Procedure: Hyaluronic acid injection
Injection in one side with autologous fat and the other side with hyaluronic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with satisfactory objective cosmetic and functional outcome
Time Frame: 2 years
Evaluation of photographs (1 to 3/Normalized to disfiguring)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of injected substance measured by ultrasonography
Time Frame: 2 years
ml
2 years
Number and type of complications
Time Frame: 2 years
Hematoma, infection, embolization.
2 years
Number of reinjections
Time Frame: 2 years
Number.
2 years
Number of patients with satisfactory subjective cosmetic and functional
Time Frame: 2 years
Patient reported perception of outcome (1 to 3/Normalized to disfiguring)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Eyvind Rødahl, MD PhD, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimated)

February 29, 2016

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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