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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous fat grafting | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous fat grafting to the orbit | Procedure | subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
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| Label | URL |
|---|---|
| further information | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 5, 2019 | |
| Reset | Sep 10, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 5, 2019 | Sep 10, 2019 |
| ID | Term |
|---|---|
| C564245 | Platelet Glycoprotein IV Deficiency |
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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