Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Orbital Fat Atrophy Clinical Trial

Official title:

Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416233
• Other study ID #: 10.27
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 10, 2017

Study information

• Verified date: August 2018
• Source: Fox, Donald Munro, M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 10, 2017
• Est. primary completion date: December 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Orbital Fat Atrophy

Intervention

Procedure:
• autologous fat grafting to the orbit
subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fox, Donald Munro, M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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