Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Study Overview
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Brief Summary
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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
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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.

Official Title
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Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Conditions
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Orbital Fat Atrophy

Intervention / Treatment
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* Procedure: autologous fat grafting to the orbit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous fat grafting<br>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<br>* subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat, autologous, orbit, atrophy, cannula