Recruiting

Spacer Graft

Sponsor:

Montefiore Medical Center

Code:

NCT04140734

Conditions

Eyelid Diseases

Eyelid Droop

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Spacer Graft

Study Details

Brief 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)

Conditions

Eyelid Diseases

Eyelid Droop

Study ID

NCT04140734

Start date

Aug 1, 2021

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hard Palate

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

experimental: Autologous Ear Cartilage

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

experimental: Porcine Acellular Dermal Matrix

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

Interventions

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.

Primary outcome measure

  • Lower Eyelid Height [ Time Frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively ]

Central Contacts and Locations

Central contacts

Anne Barmettler, MD

(978) 886-7122abarmett@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

More Information

Sponsor

Montefiore Medical Center

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Retraction Repair
  • Hard Palate
  • Autologous Ear Cartilage
  • porcine acellular dermal matrix
  • spacer graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-04-21.