Orbital Atrophy
Conditions
Brief summary
immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat
Detailed description
Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process. This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with Clinical Trials.gov
Interventions
PROCEDUREfat, PRP, botulinum toxin
fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
DRUGbotulinum toxin
botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.
DEVICEPRP
autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting
Sponsors
Fox, Donald Munro, M.D., P.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75
Exclusion criteria
* radiated orbits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orbital volume | one year | Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI |
Countries
United States
Outcome results
None listed