Thyroid-Associated OphthalmopathyNCT02693808
New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression
A study testing Autologous fat injection and Hyaluronic acid injection in people with Thyroid-Associated Ophthalmopathy, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid-Associated Ophthalmopathy
- What is being tested?
- Autologous fat injection and Hyaluronic acid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disfiguring temporal hollowing after lateral wall decompression.
- The participant want treatment for temporal hollowing
Who cannot join
- The participant dont want treatment for temporal hollowing
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Ophthalmology Haukeland University Hospital
Bergen, Hordaland, 5021
About this study
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.
Read the 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.
- Conditions
- Thyroid-Associated Ophthalmopathy
- Being tested
- Autologous fat injection, Hyaluronic acid injection
- Keywords
- Temporal hollowing, Lateral orbital wall decompression, Thyroid eye disease
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat injectionProcedure or surgery
Injection in one side with autologous fat and the other side with hyaluronic acid.
Hyaluronic acid injectionProcedure or surgery
Injection in one side with autologous fat and the other side with hyaluronic acid.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Autologous fat injection; Procedure: 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. Receives: Procedure: Autologous fat injection; Procedure: Hyaluronic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with satisfactory objective cosmetic and functional outcome
Evaluation of photographs (1 to 3/Normalized to disfiguring)
Measured: 2 years
Secondary outcomes (4)
Volume of injected substance measured by ultrasonography
ml
Measured: 2 years
Number and type of complications
Hematoma, infection, embolization.
Measured: 2 years
Number of reinjections
Number.
Measured: 2 years
Number of patients with satisfactory subjective cosmetic and functional
Patient reported perception of outcome (1 to 3/Normalized to disfiguring)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid-Associated OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eyvind Rødahl, MD PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693808
- Sponsor's protocol ID
- 2015/1175
- Status last verified
- Feb 2024
- First submitted
- 4 Dec 2015
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22627443Ueland 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.
PubMed 30679116
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression
- ClinicalTrials.gov ID
- NCT02693808
- Acronym / sponsor ID
- 2015/1175
- Conditions
- Thyroid-Associated Ophthalmopathy
- Keywords
- Temporal hollowing, Lateral orbital wall decompression, Thyroid eye disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous fat injection | Active comparator | Procedure: Autologous fat injection, Procedure: Hyaluronic acid injectionPatients 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. |
| Hyaluronic acid injection | Active comparator | Procedure: Autologous fat injection, Procedure: Hyaluronic acid injectionPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Disfiguring temporal hollowing after lateral wall decompression.
- The participant want treatment for temporal hollowing
Key exclusion criteria (1 listed)
- The participant dont want treatment for temporal hollowing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous fat injectionInjection in one side with autologous fat and the other side with hyaluronic acid. | Procedure or surgery | Autologous fat injection, Hyaluronic acid injection |
| Hyaluronic acid injectionInjection in one side with autologous fat and the other side with hyaluronic acid. | Procedure or surgery | Autologous fat injection, Hyaluronic acid injection |
Primary outcome
Number of patients with satisfactory objective cosmetic and functional outcome
Time frame: 2 years
Evaluation of photographs (1 to 3/Normalized to disfiguring)
4 secondary outcomes
Volume of injected substance measured by ultrasonography
Time frame: 2 years
Number and type of complications
Time frame: 2 years
Number of reinjections
Time frame: 2 years
Number of patients with satisfactory subjective cosmetic and functional
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 22627443McNichols 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 publication: PubMed 30679116Ueland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyvind Rødahl, MD PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous fat injection and Hyaluronic acid injection in people with Thyroid-Associated Ophthalmopathy, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with satisfactory objective cosmetic and functional outcome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.