Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
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.
|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: 1-5 years ] [ Designated as safety issue: Yes ]Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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
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.
|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|