Orbital Fat AtrophyNCT01416233
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
A study testing autologous fat grafting to the orbit in people with Orbital Fat Atrophy, run by Fox, Donald Munro, M.D., P.C. at 1 site in United States.
Trial summary
After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Orbital Fat Atrophy
- What is being tested?
- autologous fat grafting to the orbit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 10 Dec 2017
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting
- standard sphere or integrated orbital implantation
- phthisis bulbi are candidates
Who cannot join
- class 3 or greater anesthesia risk
- infection
- inability to follow study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye and Ear Infirmary
New York, New York, 10003
About this study
After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.
Read the detailed description
To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis.
To date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. The study period has been extended to include MRIs at 2 and 5 years after injection.
- Conditions
- Orbital Fat Atrophy
- Being tested
- autologous fat grafting to the orbit
- Keywords
- autologous, fat, orbit, atrophy, cannula
- Medical subject headings
- Platelet Glycoprotein IV Deficiency, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous fat grafting to the orbitProcedure or surgery
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
| Study group | Role | What they receive |
|---|---|---|
| autologous fat grafting | Experimental | There is one arm of this study. People with anophthalmic sockets and orbital atrophy are given a single session of autologous fat grafting by a closed cannula technique and are observed to measure, by MRI, the amount of fat retained at one year Receives: Procedure: autologous fat grafting to the orbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startSep 2010
- Primary completion10 Dec 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital Fat AtrophyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox, Donald Munro, M.D., P.C.
- Responsible party
- Principal investigator, Donald M Fox, MD, Fox, Donald Munro, M.D., P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416233
- Sponsor's protocol ID
- 10.27
- Status last verified
- Aug 2018
- First submitted
- 30 May 2011
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
- ClinicalTrials.gov ID
- NCT01416233
- Acronym / sponsor ID
- 10.27
- Conditions
- Orbital Fat Atrophy
- Keywords
- autologous, fat, orbit, atrophy, cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fox, Donald Munro, M.D., P.C.
- Study start
- Sep 2010
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 12 Aug 2011 (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.
After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.
Detailed description
To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis.
To date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. The study period has been extended to include MRIs at 2 and 5 years after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous fat grafting | Experimental | Procedure: autologous fat grafting to the orbitThere is one arm of this study. People with anophthalmic sockets and orbital atrophy are given a single session of autologous fat grafting by a closed cannula technique and are observed to measure, by MRI, the amount of fat retained at one year |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting
- standard sphere or integrated orbital implantation
- phthisis bulbi are candidates
Key exclusion criteria (3 listed)
- class 3 or greater anesthesia risk
- infection
- inability to follow study protocol
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 grafting to the orbitsubjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit | Procedure or surgery | autologous fat grafting |
Primary outcome
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
Time frame: 1-5 years
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
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 20 Aug 2018.
- further informationLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 grafting to the orbit in people with Orbital Fat Atrophy, run by Fox, Donald Munro, M.D., P.C. at 1 site in United States.
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 3 inclusion and 3 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 20 Aug 2018. 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 United States. 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?
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique (time frame: 1-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.