Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

NCT ID: NCT01416233

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-12-10

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.

Conditions

Orbital Fat Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous fat grafting

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

Group Type: EXPERIMENTAL

autologous fat grafting to the orbit

Intervention Type: PROCEDURE

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

Interventions

autologous fat grafting to the orbit

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDIV

Sponsor Role: lead

Responsible Party

Donald M Fox, MD

Fox, Donald Munro, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New York Eye and Ear Infirmary

New York, New York, United States

Countries

United States

Related Links

http://www.newyorkfami.com

further information

Other Identifiers

10.27

Identifier Type: -

Identifier Source: org_study_id