Spacer Graft Study

Eyelid Diseases Clinical Trial

Official title: Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts

Status Recruiting

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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Eyelid Diseases
• Eyelid Droop

• NCT number: NCT04140734
• Study type: Interventional
• Source: Montefiore Medical Center
• Contact: Anne Barmettler, MD
• Phone: (978) 886-7122
• Email: abarmett@montefiore.org
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Completion date: July 2027