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New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

Primary Purpose

Thyroid-Associated Ophthalmopathy

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Autologous fat injection
Hyaluronic acid injection
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid-Associated Ophthalmopathy focused on measuring Temporal hollowing, Lateral orbital wall decompression, Thyroid eye disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Autologous fat injection

Hyaluronic acid injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients with satisfactory objective cosmetic and functional outcome
Evaluation of photographs (1 to 3/Normalized to disfiguring)

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2015
Last Updated
February 21, 2019
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02693808
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid-Associated Ophthalmopathy
Keywords
Temporal hollowing, Lateral orbital wall decompression, Thyroid eye disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous fat injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hyaluronic acid injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous fat injection
Intervention Description
Injection in one side with autologous fat and the other side with hyaluronic acid.
Intervention Type
Procedure
Intervention Name(s)
Hyaluronic acid injection
Intervention Description
Injection in one side with autologous fat and the other side with hyaluronic acid.
Primary Outcome Measure Information:
Title
Number of patients with satisfactory objective cosmetic and functional outcome
Description
Evaluation of photographs (1 to 3/Normalized to disfiguring)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Volume of injected substance measured by ultrasonography
Description
ml
Time Frame
2 years
Title
Number and type of complications
Description
Hematoma, infection, embolization.
Time Frame
2 years
Title
Number of reinjections
Description
Number.
Time Frame
2 years
Title
Number of patients with satisfactory subjective cosmetic and functional
Description
Patient reported perception of outcome (1 to 3/Normalized to disfiguring)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyvind Rødahl, MD PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology Haukeland University Hospital
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22627443
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.
Results Reference
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New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

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