Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fox, Donald Munro, M.D., P.C.
Sponsor:
Information provided by (Responsible Party):
Fox, Donald Munro, M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01712555
First received: October 20, 2012
Last updated: February 23, 2014
Last verified: February 2014
  Purpose

After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).


Condition Intervention
Orbital Atrophy
Procedure: autologous fat grafting with PRP to anophthalmic orbits

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique

Resource links provided by NLM:


Further study details as provided by Fox, Donald Munro, M.D., P.C.:

Primary Outcome Measures:
  • Improved retention of autologous fat injected into anophthalmic sockets [ Time Frame: 1-5 yrs ] [ Designated as safety issue: Yes ]
    Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma)


Estimated Enrollment: 5
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous fat grafting with PRP to anophthalmic orbits
There is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for one year for evidence of retention of the injected fat
Procedure: autologous fat grafting with PRP to anophthalmic orbits

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: anophthalmos, orbital atrophy -

Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712555

Contacts
Contact: Donald M Fox, MD (212) 772-1500 dmfmdjr@yahoo.com

Locations
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Donald M Fox, MD    212-772-1500    dmfmdjr@Yahoo.com   
Contact: Donald M Fox, MD    212 772-1500    dmfmdjr@Yahoo.com   
Principal Investigator: Donald M Fox, MD         
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Donald Fox, MD    212-772-1500    dmfmdjr@Yahoo.com   
Contact: Donald Fox, MD       dmfmdjr@Yahoo.com   
Principal Investigator: Donald M Fox, MD         
Sponsors and Collaborators
Fox, Donald Munro, M.D., P.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Fox, Donald Munro, M.D., P.C.
ClinicalTrials.gov Identifier: NCT01712555     History of Changes
Other Study ID Numbers: New York Eye and Ear Infirmary
Study First Received: October 20, 2012
Last Updated: February 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fox, Donald Munro, M.D., P.C.:
Anophthalmic orbits
autologous fat
platelet rich plasma
orbital atrophy
anophthalmos
cannula

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014