Trial | NCT02244671  Report issue

Official Title

Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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
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
Study Started
Jan 31
2014
Primary Completion
Jan 03
2018
Study Completion
Jan 03
2018
Last Update
Aug 20
2018

Procedure fat, PRP, botulinum toxin

fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin

  • Other names: fat atrophy, absence of original eye, phthisis bulbi

Drug botulinum toxin

botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.

  • Other names: botulinum toxins

Device PRP

autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting

  • Other names: platelet rich plasma

fat, PRP, botulinum toxin Experimental

Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin

Criteria 

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
No Results Posted