Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

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

Status: Completed

Conditions: Orbital Fat Atrophy

Treatments: Procedure: autologous fat grafting to the orbit

Study type: Interventional

Identifiers

NCT01416233

10.27

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 6 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

autologous fat grafting

Experimental group

Description:

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

Treatment:

Procedure: autologous fat grafting to the orbit