Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Orbital Fat Atrophy |
Procedure: autologous fat grafting to the orbit |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique |
- Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique [ Time Frame: one year ] [ Designated as safety issue: Yes ]Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: autologous fat grafting
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
|
Procedure: autologous fat grafting to the orbit
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
|
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
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- class 3 or greater anesthesia risk
- infection
- inability to follow study protocol
Contacts and Locations| Contact: Donald M Fox, MD | 212 772-1500 | dmfmdjr@Yahoo.com |
| United States, New York | |
| New York Eye and Ear Infirmary | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Donald Fox 212-543-3180 dmfmdjr@Yahoo.com | |
| Contact: Donald Fox 212 543-3180 dmfmdjr@Yahoo.com | |
| Principal Investigator: Donald M Fox, MD | |
More Information
No publications provided
| Responsible Party: | Donald M Fox, MD, Fox, Donald Munro, M.D., Fox, Donald Munro, M.D., P.C. |
| ClinicalTrials.gov Identifier: | NCT01416233 History of Changes |
| Other Study ID Numbers: | 10.27 |
| Study First Received: | May 30, 2011 |
| Last Updated: | October 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fox, Donald Munro, M.D., P.C.:
|
autologous fat orbit atrophy cannula |
Additional relevant MeSH terms:
|
Atrophy Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013