Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Completed · Not applicable

Conditions studied: Orbital Fat Atrophy

In brief

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.

Key facts

Study ID

NCT01416233

Run by

Fox, Donald Munro, M.D., P.C.

People needed

6

Starts

2010-09-01

Expected to finish

2017-12-10

Last updated by the study team

2018-08-20

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• class 3 or greater anesthesia risk
• infection
• inability to follow study protocol

Where it is running

• New York Eye and Ear Infirmary — New York, New York, United States

Full record on ClinicalTrials.gov

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