An interventional study of fat, PRP, botulinum toxin and botulinum toxin in Orbital Atrophy, sponsored by Fox, Donald Munro, M.D., P.C.. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by Fox, Donald Munro, M.D., P.C. · Not applicable, Interventional, and Treatment
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
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 6 is below the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →Fox, Donald Munro, M.D., P.C. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
Procedure: fat, PRP, botulinum toxin · Drug: botulinum toxin · Device: PRP
fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
Also known as: fat atrophy, absence of original eye, phthisis bulbi
botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.
Also known as: botulinum toxins
autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting
Also known as: platelet rich plasma
Orbital volume
Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI
Time frame: one year
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Fox, Donald Munro, M.D., P.C.