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RECRUITING
NCT04140734
NA

Spacer Graft Study

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-08-01

Completion Date

2027-07

Last Updated

2025-01-30

Healthy Volunteers

Yes

Interventions

DEVICE

Spacer 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.

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States