Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
Montefiore Medical Center
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. 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, supporti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022 Exclusion Criteria: * Younger than 18 years old * Required concurrent surgeries (e.g., midface lift or full thickness skin graft) or required further surgeries on the operated eyelid within the 6 months postoperatively * Patients with less than 1-month follow up will be excluded from all outcome analysis and those without postoperative 6-month data will be excluded from the postoperative month 6 MRD2 calculation
Interventions
- DeviceSpacer Graft
In this prospective, randomized clinical trial, patients who will already be undergoing lower eyelid retraction repair with a spacer graft will randomly be assigned via a randomization web-site to receive 1 of 3 spacer grafts: hard palate, autologous auricular cartilage, and porcine acellular dermal matrix (Enduragen). Both the patient and the surgeon will know which of the three possible grafts are being used.
Location
- Montefiore Medical CenterThe Bronx, New York