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OpenTrials
Completed

NCT Number: NCT02244671

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

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

Completed

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Key information

Conditions

Orbital Atrophy

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Eye and Ear Infirmary

New York, 10003, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fat, PRP, botulinum toxin

Procedure

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

Botulinum toxin

Drug

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

Other names: botulinum toxins

PRP

Device

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

Other names: platelet rich plasma

Primary outcomes

  1. Orbital volume

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

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

Indiv

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2014
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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