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

Not Applicable

Completed

• Conditions: Orbital Atrophy
• Interventions: Procedure: fat, PRP, botulinum toxin; Drug: botulinum toxin; Device: PRP

• Registration Number: NCT02244671
• Lead Sponsor: Fox, Donald Munro, M.D., P.C.

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2018-01-03
• Study Completion: 2018-01-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fat, PRP, botulinum toxin	botulinum toxin	Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
fat, PRP, botulinum toxin	fat, PRP, botulinum toxin	Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
fat, PRP, botulinum toxin	PRP	Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin

Primary Outcome Measures

Name	Time	Method
Orbital volume	one year	Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI

Trial Locations

Locations (1)

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States