Comparing different spacer grafts for eyelid retraction repair
Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT04140734 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients younger than 18 years old or those requiring concurrent surgeries will not benefit from this study.
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 performed: Previous studies have shown mixed results regarding the effectiveness of different spacer graft materials, indicating that this approach is still being explored.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.