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

Fox, Donald Munro, M.D., P.C.

Status: Completed

Conditions: Orbital Atrophy

Treatments: Drug: botulinum toxin; Procedure: fat, PRP, botulinum toxin; Device: PRP

Study type: Interventional

Identifiers

NCT02244671

13.27

Details and patient eligibility

About

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

Full 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

Enrollment: 6 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

fat, PRP, botulinum toxin

Experimental group

Description:

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

Treatment:

Device: PRP

Procedure: fat, PRP, botulinum toxin

Drug: botulinum toxin