NCT02693808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

December 4, 2015

Last Update Submit

February 29, 2024

Conditions

Thyroid-Associated Ophthalmopathy

Keywords

Temporal hollowingLateral orbital wall decompressionThyroid eye disease

Outcome Measures

Primary Outcomes (1)

  • Number of patients with satisfactory objective cosmetic and functional outcome

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

    2 years

Secondary Outcomes (4)

  • 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

Study Arms (2)

Autologous fat injection

ACTIVE COMPARATOR

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 injectionProcedure: Hyaluronic acid injection

Hyaluronic acid injection

ACTIVE COMPARATOR

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 injectionProcedure: Hyaluronic acid injection

Interventions

Autologous fat injectionPROCEDURE

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

Autologous fat injectionHyaluronic acid injection
Hyaluronic acid injectionPROCEDURE

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

Autologous fat injectionHyaluronic acid injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disfiguring temporal hollowing after lateral wall decompression.
  • The participant want treatment for temporal hollowing
  • The participant dont want treatment for temporal hollowing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Related 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.

    PMID: 22627443BACKGROUND

  • 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.

    PMID: 30679116RESULT

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Eyvind Rødahl, MD PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

February 29, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2018

Study Completion

May 1, 2018

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)