Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

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.

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Key information

Conditions

Orbital Fat Atrophy Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Eye and Ear Infirmary

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous fat grafting to the orbit

Procedure

subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit

Primary outcomes

Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique

Time frame: 1-5 years

Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume

Sponsors and collaborators

Lead sponsor

Fox, Donald Munro, M.D., P.C.

Indiv

Registry information

Important dates

Study start: 2010
Primary completion: 2017
Study completion: 2017
First posted: Aug 12, 2011
Registry last updated: Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed