Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
This study is currently recruiting participants.
Verified October 2012 by Fox, Donald Munro, M.D., P.C.
Sponsor:
Fox, Donald Munro, M.D., P.C.
Information provided by (Responsible Party):
Fox, Donald Munro, M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01712555
First received: October 20, 2012
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Orbital Atrophy |
Procedure: autologous fat grafting with PRP to anophthalmic orbits |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique |
Resource links provided by NLM:
Further study details as provided by Fox, Donald Munro, M.D., P.C.:
Primary Outcome Measures:
- Improved retention of autologous fat injected into anophthalmic sockets [ Time Frame: 1-2 yrs ] [ Designated as safety issue: Yes ]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)
| Estimated Enrollment: | 5 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: autologous 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 one year for evidence of retention of the injected fat
|
Procedure: autologous fat grafting with PRP to anophthalmic orbits |
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria: anophthalmos, orbital atrophy -
Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712555
Contacts
| Contact: Donald M Fox, MD | (212) 772-1500 | dmfmdjr@yahoo.com |
Locations
| United States, New York | |
| New York Eye and Ear Infirmary | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Donald M Fox, MD 212-772-1500 dmfmdjr@Yahoo.com | |
| Contact: Donald M Fox, MD 212 772-1500 dmfmdjr@Yahoo.com | |
| Principal Investigator: Donald M Fox, MD | |
| New York Eye and Ear Infirmary | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Donald Fox, MD 212-772-1500 dmfmdjr@Yahoo.com | |
| Contact: Donald Fox, MD dmfmdjr@Yahoo.com | |
| Principal Investigator: Donald M Fox, MD | |
Sponsors and Collaborators
Fox, Donald Munro, M.D., P.C.
More Information
Additional Information:
No publications provided
| Responsible Party: | Fox, Donald Munro, M.D., P.C. |
| ClinicalTrials.gov Identifier: | NCT01712555 History of Changes |
| Other Study ID Numbers: | New York Eye and Ear Infirmary |
| Study First Received: | October 20, 2012 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fox, Donald Munro, M.D., P.C.:
|
Anophthalmic orbits autologous fat platelet rich plasma |
orbital atrophy anophthalmos cannula |
Additional relevant MeSH terms:
|
Atrophy Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013