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

Sponsor

Fox, Donald Munro, M.D., P.C. (Other)

Overall Status

Completed

CT.gov ID

NCT01712555

Collaborator

(none)

Enrollment

Location

Arm

72.5

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Orbital Atrophy	Procedure: autologous fat grafting with PRP to anophthalmic orbits	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique

Actual Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Dec 15, 2017

Actual Study Completion Date :

Dec 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 at least one year for evidence of retention of the injected fat	Procedure: autologous fat grafting with PRP to anophthalmic orbits

Arm

Intervention/Treatment

Experimental: 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 at least one year for evidence of retention of the injected fat

Procedure: autologous fat grafting with PRP to anophthalmic orbits

Outcome Measures

Primary Outcome Measures

Improved retention of autologous fat injected into anophthalmic sockets [1-5 yrs]
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)