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

Not Applicable
Completed
Conditions
Orbital Atrophy
Interventions
Procedure: autologous fat grafting with PRP to anophthalmic orbits
Registration Number
NCT01712555
Lead Sponsor
Fox, Donald Munro, M.D., P.C.
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5
Inclusion Criteria

anophthalmos, orbital atrophy -

Exclusion Criteria

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
fat grafting with PRP to anophthalmic orbitsautologous fat grafting with PRP to anophthalmic orbitsThere 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
Primary Outcome Measures
NameTimeMethod
Improved retention of autologous fat injected into anophthalmic sockets1-5 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York Eye and Ear Infirmary

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New York, New York, United States

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