Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01416233

Enrollment

Registered

2011-08-12

Start date

2010-09-30

Completion date

2017-12-10

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital Fat Atrophy

Keywords

autologous, fat, orbit, atrophy, cannula

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 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

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.

Interventions

PROCEDUREautologous fat grafting to the orbit

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique	1-5 years	Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026