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NCT01416233 · ClinicalTrials.gov registry record · NA
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
A NA study of Orbital Fat Atrophy, sponsored by Fox, Donald Munro, M.D., P.C..
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01416233: Completed NA study of Orbital Fat Atrophy, sponsored by Fox, Donald Munro, M.D., P.C..
NCT01416233 is a NA study of Orbital Fat Atrophy that has completed, run by Fox, Donald Munro, M.D., P.C.. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416233, a NA study of Orbital Fat Atrophy, has completed, sponsored by Fox, Donald Munro, M.D., P.C..
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.
Primary Outcome
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
Conditions Studied
Interventions
- PROCEDURE autologous fat grafting to the orbit
Study Locations (1)
New York
- New York Eye and Ear Infirmary - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-09 |
| Est. Completion | 2017-12-10 |
| Phase | NA |
What the finished NCT01416233 record still lists
NCT01416233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Orbital Fat Atrophy appearing as the primary indexed condition, and to 1 intervention - of which autologous fat grafting to the orbit is the first listed.
NCT01416233 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01416233 about?
NCT01416233 is a clinical study titled "Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique". After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require o...
What is the current status of trial NCT01416233?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2010-09. Estimated completion is 2017-12-10.
What conditions does trial NCT01416233 study?
This clinical trial studies the following conditions: Orbital Fat Atrophy.
What interventions are being tested in trial NCT01416233?
The interventions under investigation include: autologous fat grafting to the orbit (PROCEDURE).
Who is sponsoring clinical trial NCT01416233?
This trial is sponsored by Fox, Donald Munro, M.D., P.C., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01416233 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416233's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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