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Spacer Graft Study

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ClinicalTrials.gov Identifier: NCT04140734
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

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)

Condition or disease Intervention/treatment Phase
Eyelid Diseases Eyelid Droop Device: Spacer Graft Not Applicable

Detailed Description:

Lower eyelid retraction is a common eyelid malposition, typically caused by thyroid eye disease, excessive resection of skin in a cosmetic lower eyelid blepharoplasty, vertical rectus muscle recession, facial nerve paralysis, or a normal anatomical variant.[1] When the lower eyelid is displaced inferiorly, exposing sclera between the limbus and the eyelid margin, symptoms can vary from ocular irritation and discomfort to vision threatening corneal decompensation. If medical management does not suffice, surgery is indicated.

Although lower eyelid retractor lysis alone has been described, supporting material (spacer graft) placed to augment the posterior lamella is generally required for more effective elevation of the eyelid.[2] Various materials have been utilized, including autologous auricular cartilage, bovine acellular dermal matrix, porcine acellular dermal matrix, hard palate mucosa, dermis and dermis fat grafts. Previous studies on acellular dermal matrix use in lower eyelid retraction repair consist of retrospective efficacy studies with only 2 comparative studies. However, conflicting results raised doubt as to which material was superior. In addition, a prospective, randomized comparative study of spacer grafts used for lower eyelid retraction repair was done comparing autologous auricular cartilage, porcine acellular dermal matrix, and bovine acellular dermal matrix. The results yielded no statistically significant difference in surgical outcomes and complications.[3]. As of now, surgery with any of the spacer grafts, including autologous hard palate, is accepted as standard of care. [4] This study is designed to determine whether using hard palate as a spacer graft will have statistically significant different surgical outcomes and complications as compared to autologous ear cartilage and porcine acellular dermal matrix spacer grafts. Although studied separately, this has not been studied before in a prospective randomized manner and may prove to demonstrate improved surgical results and decreased complications. This can guide future choice of spacer graft used in lower eyelid retraction repair surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : June 1, 2023

Arm Intervention/treatment
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
Device: 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.

Active Comparator: 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
Device: 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.

Active Comparator: 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
Device: 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 Measures :
  1. MRD2 (margin to reflex distance 2) [ Time Frame: 6 months post-op ]
    Analyzing the effectiveness of the spacer grafts with respect to lower eyelid retraction repair. MRD2 is the distance in millimeters between the pupillary light reflex and the lower eyelid margin with the patient looking at a light reflex in primary gaze.


Secondary Outcome Measures :
  1. Post-Surgical Complications [ Time Frame: 6 months post-op ]
    Conjunctival injection and eyelid swelling will be graded by the examiner on a scale of 0 to 10. Tearing, itching, discomfort will be graded by the patient on a scale of 0 to 10 both pre-operatively and post-operatively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients will be included if they undergo lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022 .

Exclusion Criteria:

  • Patients will be excluded if they are 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. In addition, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140734


Contacts
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Contact: Anne Barmettler, MD (978) 886-7122 abarmett@montefiore.org
Contact: Jose Rosado 7189202020 jrosado@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Jose Rosado    718-920-2020    jrosado@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Anne Barmettler, MD Director of Oculoplastic Surgery Division
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04140734    
Other Study ID Numbers: 2019-10410
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Montefiore Medical Center:
Retraction Repair
Hard Palate
Autologous Ear Cartilage
porcine acellular dermal matrix
spacer graft
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases