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Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fox, Donald Munro, M.D., P.C.
Sponsor:
Information provided by (Responsible Party):
Donald M Fox, MD, Fox, Donald Munro, M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01416233
First received: May 30, 2011
Last updated: February 23, 2014
Last verified: February 2014

May 30, 2011
February 23, 2014
September 2010
September 2014   (final data collection date for primary outcome measure)
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
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
Complete list of historical versions of study NCT01416233 on ClinicalTrials.gov Archive Site
Not Provided
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Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Orbital Fat Atrophy
Procedure: autologous fat grafting to the orbit
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
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
Intervention: Procedure: autologous fat grafting to the orbit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2018
September 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
Yes
Contact: Donald M Fox, MD 212 772-1500 dmfmdjr@Yahoo.com
United States
 
NCT01416233
10.27
Yes
Donald M Fox, MD, Fox, Donald Munro, M.D., P.C.
Fox, Donald Munro, M.D., P.C.
Not Provided
Not Provided
Fox, Donald Munro, M.D., P.C.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP