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
  Purpose

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.


Condition Intervention
Orbital Fat Atrophy
Procedure: autologous fat grafting to the orbit

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Further study details as provided by Fox, Donald Munro, M.D., P.C.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: autologous fat grafting to the orbit
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416233

Contacts
Contact: Donald M Fox, MD 212 772-1500 dmfmdjr@Yahoo.com

Locations
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Donald Fox    212-543-3180    dmfmdjr@Yahoo.com   
Contact: Donald Fox    212 543-3180    dmfmdjr@Yahoo.com   
Principal Investigator: Donald M Fox, MD         
Sponsors and Collaborators
Fox, Donald Munro, M.D., P.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Donald M Fox, MD, Fox, Donald Munro, M.D., Fox, Donald Munro, M.D., P.C.
ClinicalTrials.gov Identifier: NCT01416233     History of Changes
Other Study ID Numbers: 10.27
Study First Received: May 30, 2011
Last Updated: February 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fox, Donald Munro, M.D., P.C.:
autologous
fat
orbit
atrophy
cannula

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014