RecruitingNot Applicable

Spacer Graft Study

United States100 participantsStarted 2021-08-01

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lower Eyelid Height

Timeframe: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively

Trial details

NCT IDNCT04140734

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

Anne Barmettler, MD

(978) 886-7122 abarmett@montefiore.org

View on ClinicalTrials.gov More Eyelid Diseases trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.