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

Sponsor
Fox, Donald Munro, M.D., P.C. (Other)
Overall Status
Completed
CT.gov ID
NCT02244671
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
48.1
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: fat, PRP, botulinum toxin
  • Drug: botulinum toxin
  • Device: PRP
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 3, 2018
Actual Study Completion Date :
Jan 3, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: fat, PRP, botulinum toxin

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Orbital volume [one year]

      Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Eye and Ear Infirmary New York New York United States 10003

    Sponsors and Collaborators

    • Fox, Donald Munro, M.D., P.C.

    Investigators

    • Principal Investigator: Donald M Fox, MD, New York Eye and Ear Infirmary

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Fox, Donald Munro, M.D., P.C.
    ClinicalTrials.gov Identifier:
    NCT02244671
    Other Study ID Numbers:
    • 13.27
    First Posted:
    Sep 19, 2014
    Last Update Posted:
    Aug 20, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Atrophy
    Botulinum Toxins

    Study Results

    No Results Posted as of Aug 20, 2018