Orbital AtrophyNCT01712555
Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
A study testing autologous fat grafting with PRP to anophthalmic orbits in people with Orbital Atrophy, run by Fox, Donald Munro, M.D., P.C. at 1 site in United States.
Trial summary
After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Orbital Atrophy
- What is being tested?
- autologous fat grafting with PRP to anophthalmic orbits
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 15 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City
- -
Who cannot join
None listed.
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
Official title: Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique
After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).
- Conditions
- Orbital Atrophy
- Being tested
- autologous fat grafting with PRP to anophthalmic orbits
- Keywords
- Anophthalmic orbits, autologous fat, platelet rich plasma, orbital atrophy, anophthalmos, cannula
- Medical subject headings
- Anophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous fat grafting with PRP to anophthalmic orbitsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| fat grafting with PRP to anophthalmic orbits | Experimental | There is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for at least one year for evidence of retention of the injected fat Receives: Procedure: autologous fat grafting with PRP to anophthalmic orbits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved retention of autologous fat injected into anophthalmic sockets
Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma)
Measured: 1-5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startDec 2011
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox, Donald Munro, M.D., P.C.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712555
- Sponsor's protocol ID
- New York Eye and Ear Infirmary
- Status last verified
- Aug 2018
- First submitted
- 20 Oct 2012
- 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 Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique
- ClinicalTrials.gov ID
- NCT01712555
- Acronym / sponsor ID
- New York Eye and Ear Infirmary
- Conditions
- Orbital Atrophy
- Keywords
- Anophthalmic orbits, autologous fat, platelet rich plasma, orbital atrophy, anophthalmos, cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fox, Donald Munro, M.D., P.C.
- Study start
- Dec 2011 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 23 Oct 2012 (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 people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fat grafting with PRP to anophthalmic orbits | Experimental | Procedure: autologous fat grafting with PRP to anophthalmic orbitsThere is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for at least one year for evidence of retention of the injected fat |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City
- -
Key exclusion criteria (0 listed)
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 with PRP to anophthalmic orbits | Procedure or surgery | fat grafting with PRP to anophthalmic orbits |
Primary outcome
Improved retention of autologous fat injected into anophthalmic sockets
Time frame: 1-5 yrs
Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma)
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.
- related infoLink 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 with PRP to anophthalmic orbits in people with Orbital 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 2 inclusion and 0 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?
Improved retention of autologous fat injected into anophthalmic sockets (time frame: 1-5 yrs). 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; AzTrials last refreshed its copy on 8 Nov 2026.