Comparing different spacer grafts for eyelid retraction repair
Official title: Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
Run by Montefiore Medical Center · NCT04140734 · Data updated 2026-11-12
This study tests which of three different types of grafts works best for fixing lower eyelid retraction in people who need surgery for this condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | August 1, 2021 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT04140734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who have undergone lower eyelid retraction repair requiring a spacer graft between July 1, 2019, and July 1, 2022.
✕Probably not a fit
Patients younger than 18 years old or those requiring concurrent surgeries will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of three types of spacer grafts—hard palate, autologous ear cartilage, and porcine acellular dermal matrix—in repairing lower eyelid retraction. Lower eyelid retraction can lead to various symptoms, including ocular irritation and potential vision issues. The study will measure outcomes using the margin to reflex distance 2 (MRD2) metric to determine which graft type provides the best surgical results. Participants will have undergone lower eyelid retraction repair requiring a spacer graft within a specified timeframe.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes for patients with lower eyelid retraction.
How similar studies have gone: Previous studies have shown mixed results regarding the effectiveness of different spacer graft materials, indicating that this approach is still being explored.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Anne Barmettler, MD — Director of Oculoplastic Surgery Division
- Study coordinator: Anne Barmettler, MD
- Email: abarmett@montefiore.org
- Phone: (978) 886-7122
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.