Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04140734 |
Other study ID # |
2019-10410 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2021 |
Est. completion date |
July 2027 |
Study information
Verified date |
January 2024 |
Source |
Montefiore Medical Center |
Contact |
Anne Barmettler, MD |
Phone |
(978) 886-7122 |
Email |
abarmett[@]montefiore.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage
vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured
by MRD2 (margin to reflex distance 2)
Description:
Lower eyelid retraction is a common eyelid malposition, typically caused by thyroid eye
disease, excessive resection of skin in a cosmetic lower eyelid blepharoplasty, vertical
rectus muscle recession, facial nerve paralysis, or a normal anatomical variant.[1] When the
lower eyelid is displaced inferiorly, exposing sclera between the limbus and the eyelid
margin, symptoms can vary from ocular irritation and discomfort to vision threatening corneal
decompensation. If medical management does not suffice, surgery is indicated.
Although lower eyelid retractor lysis alone has been described, supporting material (spacer
graft) placed to augment the posterior lamella is generally required for more effective
elevation of the eyelid.[2] Various materials have been utilized, including autologous
auricular cartilage, bovine acellular dermal matrix, porcine acellular dermal matrix, hard
palate mucosa, dermis and dermis fat grafts. Previous studies on acellular dermal matrix use
in lower eyelid retraction repair consist of retrospective efficacy studies with only 2
comparative studies. However, conflicting results raised doubt as to which material was
superior. In addition, a prospective, randomized comparative study of spacer grafts used for
lower eyelid retraction repair was done comparing autologous auricular cartilage, porcine
acellular dermal matrix, and bovine acellular dermal matrix. The results yielded no
statistically significant difference in surgical outcomes and complications.[3]. As of now,
surgery with any of the spacer grafts, including autologous hard palate, is accepted as
standard of care. [4] This study is designed to determine whether using hard palate as a
spacer graft will have statistically significant different surgical outcomes and
complications as compared to autologous ear cartilage and porcine acellular dermal matrix
spacer grafts. Although studied separately, this has not been studied before in a prospective
randomized manner and may prove to demonstrate improved surgical results and decreased
complications. This can guide future choice of spacer graft used in lower eyelid retraction
repair surgery.