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

NCT ID: NCT01712555

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-12-15

Brief Summary

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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

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Conditions

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Orbital Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

autologous fat grafting with PRP to anophthalmic orbits

Intervention Type PROCEDURE

Interventions

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autologous fat grafting with PRP to anophthalmic orbits

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fox, Donald Munro, M.D., P.C.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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New York Eye and Ear Infirmary

Identifier Type: -

Identifier Source: org_study_id

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