Orbital Fat Atrophy Clinical Trial
Official title:
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.
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.
;