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Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416233
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Donald M Fox, MD, 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.

Condition or disease Intervention/treatment Phase
Orbital Fat Atrophy Procedure: autologous fat grafting to the orbit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Study Start Date : September 2010
Actual Primary Completion Date : December 10, 2017
Actual Study Completion Date : December 10, 2017

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique [ Time Frame: 1-5 years ]
    Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416233


Locations
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United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
Fox, Donald Munro, M.D., P.C.
Additional Information:
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Responsible Party: Donald M Fox, MD, Fox, Donald Munro, M.D., Fox, Donald Munro, M.D., P.C.
ClinicalTrials.gov Identifier: NCT01416233    
Other Study ID Numbers: 10.27
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Keywords provided by Donald M Fox, MD, Fox, Donald Munro, M.D., P.C.:
autologous
fat
orbit
atrophy
cannula
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical