Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique - Tabular View

Tracking Information

First Received Date ^ICMJE

May 30, 2011

Last Updated Date

August 11, 2011

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01416233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

Official Title ^ICMJE

Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

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

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Orbital Fat Atrophy

Intervention ^ICMJE

Procedure: autologous fat grafting to the orbit

subjects will undergo fat harvesting followed by injection of the fat into the orbit

Study Arms

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Donald M Fox, MD

212 772-1500

dmfmdjr@Yahoo.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01416233

Other Study ID Numbers ^ICMJE

10.27

Has Data Monitoring Committee

Yes

Responsible Party

Donald Munro Fox, MD Principle investigator, Donald Munro Fox, MD PC

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

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

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP