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Spacer Grafts for Lower Eyelid Retraction
N/A
Recruiting
Led By Anne Barmettler, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-op
Awards & highlights
Study Summary
This trial will compare the outcomes of three types of spacer grafts used to repair lower eyelid retraction.
Who is the study for?
This trial is for patients who need a spacer graft for lower eyelid retraction repair and are over 18 years old. They must have had the surgery between July 2019 and July 2022, with at least one month of follow-up data, but no additional eye surgeries within six months after.Check my eligibility
What is being tested?
The study compares three types of spacer grafts—hard palate, autologous ear cartilage, and Enduragen—to see which is most effective in repairing lower eyelid retraction by measuring the change in MRD2 (distance from the margin to reflex).See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the graft site, infection risk, or issues related to general surgical procedures on the eyelids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRD2 (margin to reflex distance 2)
Secondary outcome measures
Post-Surgical Complications
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Hard PalateExperimental Treatment1 Intervention
Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate
Group II: Autologous Ear CartilageActive Control1 Intervention
Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage
Group III: Porcine Acellular Dermal MatrixActive Control1 Intervention
Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,096 Total Patients Enrolled
Anne Barmettler, MDPrincipal InvestigatorDirector of Oculoplastic Surgery Division
2 Previous Clinical Trials
690 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had, nor do I need, any other eye surgeries within 6 months after my eyelid operation.I am 18 years old or older.I had surgery to fix lower eyelid drooping using a spacer graft between July 1, 2019, and July 1, 2022.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Ear Cartilage
- Group 2: Hard Palate
- Group 3: Porcine Acellular Dermal Matrix
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for enrollment in this trial?
"Confirmed, this clinical trial is still recruiting patients. Originally posted on the 1st of August 2021, its information was recently updated on February 7th 2022 according to data stored on clinicaltrials.gov."
Answered by AI
How many individuals have chosen to participate in this clinical trial?
"Affirmative. The clinical trial, which was published on August 1st 2021, is currently seeking participants according to the information presented on clinicaltrials.gov. 100 individuals must be recruited from a single location for this medical study."
Answered by AI
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