Botulinum-assisted Orbital Fat Augmentation With PRP (Pla... | NCT02244671

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

NCT02244671

Sponsor

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

Status

Completed

Last Update Posted

Aug 20, 2018Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Orbital Atrophy

Interventions

fat, PRP, botulinum toxin
botulinum toxin
PRP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 3, 2018Actual

Completion Date

Jan 3, 2018Actual

First Submitted Date

Aug 21, 2014

First Submission Date that Met QC Criteria

Sep 17, 2014

First Posted Date

Sep 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fat, PRP, botulinum toxin	Experimental	Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin	Procedure: fat, PRP, botulinum toxin Drug: botulinum toxin Device: PRP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fat, PRP, botulinum toxin	Procedure	fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin	fat, PRP, botulinum toxin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald M Fox, MD	New York Eye and Ear Infirmary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Eye and Ear Infirmary		New York	New York	10003	United States

Label	URL
fat grafting	View source

Type	Date	Date Unknown
Release	Aug 5, 2019
Reset	Aug 22, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 5, 2019			Aug 22, 2019

Intervention Browse Module

MeSH Terms

ID	Term
D018955	CD36 Antigens
D001905	Botulinum Toxins

Ancestor Terms

ID	Term
D010980	Platelet Membrane Glycoproteins
D008562	Membrane Glycoproteins
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided