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Spacer Graft Study

Primary Purpose

Eyelid Diseases, Eyelid Droop

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spacer Graft
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelid Diseases focused on measuring Retraction Repair, Hard Palate, Autologous Ear Cartilage, porcine acellular dermal matrix, spacer graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Hard Palate

Autologous Ear Cartilage

Porcine Acellular Dermal Matrix

Arm Description

Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate

Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage

Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix

Outcomes

Primary Outcome Measures

MRD2 (margin to reflex distance 2)
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

Post-Surgical Complications
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.

Full Information

First Posted
October 24, 2019
Last Updated
January 9, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04140734
Brief Title
Spacer Graft Study
Official Title
Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 22, 2024 (Anticipated)
Study Completion Date
December 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases, Eyelid Droop
Keywords
Retraction Repair, Hard Palate, Autologous Ear Cartilage, porcine acellular dermal matrix, spacer graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hard Palate
Arm Type
Experimental
Arm Description
Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate
Arm Title
Autologous Ear Cartilage
Arm Type
Active Comparator
Arm Description
Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage
Arm Title
Porcine Acellular Dermal Matrix
Arm Type
Active Comparator
Arm Description
Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix
Intervention Type
Device
Intervention Name(s)
Spacer Graft
Intervention Description
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 Measure Information:
Title
MRD2 (margin to reflex distance 2)
Description
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.
Time Frame
6 months post-op
Secondary Outcome Measure Information:
Title
Post-Surgical Complications
Description
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.
Time Frame
6 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Barmettler, MD
Phone
(978) 886-7122
Email
abarmett@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Barmettler, MD
Organizational Affiliation
Director of Oculoplastic Surgery Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Spacer Graft Study

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