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

Orbital Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244671
• Other study ID #: 13.27
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 3, 2018

Study information

• Verified date: August 2018
• Source: Fox, Donald Munro, M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 3, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Orbital Atrophy

Intervention

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

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

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

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fox, Donald Munro, M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orbital volume	Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI	one year

External Links

•   fat grafting