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

Primary Purpose

Orbital Atrophy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

fat, PRP, botulinum toxin

botulinum toxin

PRP

About this trial

This is an interventional treatment trial for Orbital Atrophy

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

New York Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fat, PRP, botulinum toxin

Arm Description

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

Outcomes

Primary Outcome Measures

Orbital volume

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02244671

First Posted

August 21, 2014

Last Updated

August 16, 2018

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02244671

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 3, 2018 (Actual)

Study Completion Date

January 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orbital Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fat, PRP, botulinum toxin

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

fat, PRP, botulinum toxin

Other Intervention Name(s)

fat atrophy, absence of original eye, phthisis bulbi

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

botulinum toxin

Other Intervention Name(s)

botulinum toxins

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PRP

Other Intervention Name(s)

platelet rich plasma

Intervention Description

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

Primary Outcome Measure Information:

Title

Orbital volume

Description

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald M Fox, MD

Organizational Affiliation

New York Eye and Ear Infirmary

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Eye and Ear Infirmary

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.newyorkfami.com

Description

fat grafting

Learn more about this trial

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

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