Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04140734

Comparison of Lower Eyelid Retraction Repair Using Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts

Led by Montefiore Medical Center · Updated on 2026-04-21

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out which of three spacer graft types—hard palate, autologous ear cartilage, or porcine acellular dermal matrix—is most effective for repairing lower eyelid retraction. Lower eyelid retraction can cause eye discomfort or vision problems and may result from thyroid eye disease, cosmetic surgery, muscle surgery, nerve paralysis, or natural anatomy. Surgery with spacer grafts is often needed when other treatments are not enough. Patients already scheduled for lower eyelid retraction repair will be randomly assigned to receive one of the three spacer grafts during surgery. The grafts being compared are hard palate tissue, ear cartilage from the patient, and a pig-derived acellular dermal matrix called Enduragen. Both the patient and surgeon will know which graft is used. The study will monitor surgical results and complications over time. Participants will be evaluated before surgery and then at 1 week, 1 month, 3 months, and 6 months after surgery. Researchers will measure eyelid height to assess repair success and track any post-surgical complications during these visits. The goal is to determine which graft type leads to the best outcomes and fewer complications, guiding better choices for future eyelid surgeries. The study is sponsored by Montefiore Medical Center and runs until July 2028.

CONDITIONS

Brief Title

Spacer Graft Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Required additional surgeries (such as midface lift or full thickness skin graft) or further eyelid surgeries within 6 months after initial surgery
  • Less than 1-month follow-up or missing 6-month postoperative data for eyelid height measurement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo lower eyelid retraction repair surgery using one of three spacer grafts: hard palate, autologous ear cartilage, or porcine acellular dermal matrix.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 6 months

Participants are monitored for eyelid height and post-surgical complications following surgery.

Visits at 1 week, 1 month, 3 months, and 6 months post-operatively

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

A

Anne Barmettler, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

A Prospective, Randomized Comparison of Lower Eyelid Retraction Repair With Autologous Auricular Cartilage, Bovine Acellular Dermal Matrix (Surgimend), and Porcine Acellular Dermal Matrix (Enduragen) Spacer Grafts.

Anne Barmettler, Moonseong Heo

https://pubmed.ncbi.nlm.nih.gov/28658181