Orbital AtrophyNCT02244671
Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
A study testing fat, PRP, botulinum toxin, botulinum toxin and PRP in people with Orbital Atrophy, run by Fox, Donald Munro, M.D., P.C. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Orbital Atrophy
- What is being tested?
- fat, PRP, botulinum toxin, botulinum toxin and PRP
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 3 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75
Who cannot join
- radiated orbits
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye and Ear Infirmary
New York, New York, 10003
About this study
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
Read the 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
- Conditions
- Orbital Atrophy
- Being tested
- fat, PRP, botulinum toxin, botulinum toxin, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat, PRP, botulinum toxinProcedure or surgery
Also called fat atrophy, absence of original eye, phthisis bulbi
fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
botulinum toxinDrug
Also called botulinum toxins
botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.
PRPDevice
Also called platelet rich plasma
autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting
| Study group | Role | What they receive |
|---|---|---|
| fat, PRP, botulinum toxin | Experimental | Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin Receives: Procedure: fat, PRP, botulinum toxin; Drug: botulinum toxin; Device: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbital volume
Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJan 2014
- Primary completion3 Jan 2018
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox, Donald Munro, M.D., P.C.
- Responsible party
- Sponsor
- Investigators
- Donald M Fox, MD, Principal investigator, New York Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244671
- Sponsor's protocol ID
- 13.27
- Status last verified
- Aug 2018
- First submitted
- 21 Aug 2014
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
- ClinicalTrials.gov ID
- NCT02244671
- Acronym / sponsor ID
- 13.27
- Conditions
- Orbital Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fox, Donald Munro, M.D., P.C.
- Study start
- Jan 2014
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fat, PRP, botulinum toxin | Experimental | Procedure: fat, PRP, botulinum toxin, Drug: botulinum toxin, Device: PRPFat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75
Key exclusion criteria (1 listed)
- radiated orbits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fat, PRP, botulinum toxinAlso: fat atrophy, absence of original eye, phthisis bulbifat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin | Procedure or surgery | fat, PRP, botulinum toxin |
| botulinum toxinAlso: botulinum toxinsbotulinum toxin used to immobilize extra-ocular muscles prior to fat injection. | Drug | fat, PRP, botulinum toxin |
| PRPAlso: platelet rich plasmaautologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting | Device | fat, PRP, botulinum toxin |
Primary outcome
Orbital volume
Time frame: one year
Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- fat graftingLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M Fox, MD principal investigator
New York Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fat, PRP, botulinum toxin, botulinum toxin and PRP in people with Orbital Atrophy, run by Fox, Donald Munro, M.D., P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbital volume (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.