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

Orbital Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712555
• Other study ID #: New York Eye and Ear Infirmary
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 15, 2017

Study information

• Verified date: August 2018
• Source: Fox, Donald Munro, M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria: anophthalmos, orbital atrophy -

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

Related Conditions & MeSH terms

• Atrophy
• Orbital Atrophy

Intervention

Procedure:
• autologous fat grafting with PRP to anophthalmic orbits

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fox, Donald Munro, M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved retention of autologous fat injected into anophthalmic sockets	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)	1-5 yrs

External Links

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