Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Primary Purpose
Orbital Fat Atrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
autologous fat grafting to the orbit
Sponsored by
About this trial
This is an interventional treatment trial for Orbital Fat Atrophy focused on measuring autologous, fat, orbit, atrophy, cannula
Eligibility 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
Sites / Locations
- New York Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
autologous fat grafting
Arm 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
Outcomes
Primary Outcome Measures
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
Secondary Outcome Measures
Full Information
NCT ID
NCT01416233
First Posted
May 30, 2011
Last Updated
August 16, 2018
Sponsor
Fox, Donald Munro, M.D., P.C.
1. Study Identification
Unique Protocol Identification Number
NCT01416233
Brief Title
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Official Title
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
December 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fox, Donald Munro, M.D., P.C.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Fat Atrophy
Keywords
autologous, fat, orbit, atrophy, cannula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous fat grafting
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
autologous fat grafting to the orbit
Intervention Description
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
Primary Outcome Measure Information:
Title
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
Description
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
Time Frame
1-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.newyorkfami.com
Description
further information
Learn more about this trial
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
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