Spacer Graft Study

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Eyelid Droop; Eyelid Diseases

Treatments: Device: Spacer Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT04140734

2019-10410

Details and patient eligibility

About

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)

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients will be included if they undergo lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022 .

Exclusion criteria

• Patients will be excluded if they are 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. In addition, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Hard Palate

Experimental group

Description:

Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate

Treatment:

Device: Spacer Graft

Autologous Ear Cartilage

Active Comparator group

Description:

Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage

Treatment:

Device: Spacer Graft

Porcine Acellular Dermal Matrix

Active Comparator group

Description:

Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix

Treatment:

Device: Spacer Graft