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

August 16, 2018 updated by: Fox, Donald Munro, M.D., P.C.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orbital volume
Time Frame: one year
Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 3, 2018

Study Completion (Actual)

January 3, 2018

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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