Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
NCT01416233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2018-08-20
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.
Conditions
- Orbital Fat Atrophy
Interventions
- PROCEDURE
-
autologous fat grafting to the orbit
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
Sponsors & Collaborators
-
Fox, Donald Munro, M.D., P.C.
lead INDIV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2017-12-10
- Completion
- 2017-12-10
Countries
- United States
Study Locations
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