Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Not Applicable

Completed

• Conditions: Orbital Fat Atrophy
• Interventions: Procedure: autologous fat grafting to the orbit

• Registration Number: NCT01416233
• Lead Sponsor: Fox, Donald Munro, M.D., P.C.

Brief Summary

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.

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.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2017-12-10
• Study Completion: 2017-12-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous fat grafting	autologous fat grafting to the orbit	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

Primary Outcome Measures

Name	Time	Method
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique	1-5 years	Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume

Trial Locations

Locations (1)

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States