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Search / Trial NCT04140734

Spacer Graft Study

Launched by MONTEFIORE MEDICAL CENTER · Oct 24, 2019

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Retraction Repair Hard Palate Autologous Ear Cartilage Porcine Acellular Dermal Matrix Spacer Graft

ClinConnect Summary

The Spacer Graft Study is looking to find out which of three different types of materials works best for fixing lower eyelid droop. The three materials being tested are hard palate (bone from the roof of the mouth), ear cartilage (from the patient’s own ear), and a product called Enduragen. The goal is to see which option helps improve eyelid position the most after surgery.

To participate in this study, you need to be between 18 and 74 years old and scheduled for lower eyelid surgery that requires a spacer graft between July 1, 2019, and July 1, 2022. Unfortunately, if you’re younger than 18, need other surgeries at the same time, or if you might need more surgery on the same eyelid within six months after your first surgery, you won't be able to join. If you do take part, you can expect to be monitored for at least six months after your surgery to see how well the chosen material works in improving your eyelid position. This research aims to help doctors understand the best options for patients with eyelid issues in the future.

Gender

ALL

Eligibility criteria

  • 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

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Anne Barmettler, MD

Principal Investigator

Director of Oculoplastic Surgery Division

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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