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

NCT ID: NCT02244671

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-01-03

Brief Summary

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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

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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

Conditions

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Orbital Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fat, PRP, botulinum toxin

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

Group Type EXPERIMENTAL

fat, PRP, botulinum toxin

Intervention Type PROCEDURE

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

botulinum toxin

Intervention Type DRUG

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

PRP

Intervention Type DEVICE

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

Interventions

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fat, PRP, botulinum toxin

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

Intervention Type PROCEDURE

botulinum toxin

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

Intervention Type DRUG

PRP

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

Intervention Type DEVICE

Other Intervention Names

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fat atrophy, absence of original eye, phthisis bulbi botulinum toxins platelet rich plasma

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald M Fox, MD

Role: PRINCIPAL_INVESTIGATOR

New York Eye and Ear Infirmary

Locations

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New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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13.27

Identifier Type: -

Identifier Source: org_study_id

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