Status:
COMPLETED
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Lead Sponsor:
Fox, Donald Munro, M.D., P.C.
Conditions:
Orbital Fat Atrophy
Eligibility:
All Genders
30-80 years
Phase:
NA
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 per...
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 incr...
Eligibility Criteria
Inclusion
- 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
- class 3 or greater anesthesia risk
- infection
- inability to follow study protocol
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01416233
Start Date
September 1 2010
End Date
December 10 2017
Last Update
August 20 2018
Active Locations (1)
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1
New York Eye and Ear Infirmary
New York, New York, United States, 10003