Back to resultsAutologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
Primary Purpose
Orbital Atrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
autologous fat grafting with PRP to anophthalmic orbits
Sponsored by
About this trial
This is an interventional treatment trial for Orbital Atrophy focused on measuring Anophthalmic orbits, autologous fat, platelet rich plasma, orbital atrophy, anophthalmos, cannula
Eligibility Criteria
Inclusion Criteria: anophthalmos, orbital atrophy -
Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City
-
Sites / Locations
- New York Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fat grafting with PRP to anophthalmic orbits
Arm Description
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01712555
First Posted
October 20, 2012
Last Updated
August 16, 2018
Sponsor
Fox, Donald Munro, M.D., P.C.
1. Study Identification
Unique Protocol Identification Number
NCT01712555
Brief Title
Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
Official Title
Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox, Donald Munro, M.D., P.C.
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Atrophy
Keywords
Anophthalmic orbits, autologous fat, platelet rich plasma, orbital atrophy, anophthalmos, cannula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fat grafting with PRP to anophthalmic orbits
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
autologous fat grafting with PRP to anophthalmic orbits
Primary Outcome Measure Information:
Title
Improved retention of autologous fat injected into anophthalmic sockets
Description
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)
Time Frame
1-5 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: anophthalmos, orbital atrophy -
Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City
-
Facility Information:
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.newyorkfami.com
Description
related info
Learn more about this trial
Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
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