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

Not Applicable

Completed

• Conditions: Orbital Atrophy

• 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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-10-20
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-23
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States