Spacer Grafts for Lower Eyelid Retraction

Recruiting at 1 trial location

Overseen By Jose Rosado

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Under 18, Concurrent surgeries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three spacer grafts best corrects lower eyelid retraction, a condition where the lower eyelid droops or pulls away from the eye. The three spacer grafts being tested include hard palate tissue, cartilage from the patient's own ear, and a material made from pig skin (porcine acellular dermal matrix). Individuals who underwent surgery to repair lower eyelid retraction with a spacer graft between July 2019 and July 2022 may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future treatments for lower eyelid retraction.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these spacer grafts are safe for lower eyelid retraction repair?

Research has shown that using cartilage from a patient's own ear in lower eyelid surgeries is generally safe and well-tolerated. Studies have found no major issues with this type of cartilage, making it a safe choice for many individuals.

For grafts from the roof of the mouth, studies have identified only minor issues, such as slight eye irritation or a temporary connection between the nose and mouth, which usually resolve on their own. This indicates that using tissue from the roof of the mouth is generally safe and effective.

Research supports the safety of using porcine acellular dermal matrix, a material made from pig skin, in eyelid surgeries. It is often used without major problems, although there is a rare chance of the graft dissolving. Discussing this with a doctor is important.

Overall, research has shown these types of grafts to be safe, but discussing individual risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lower eyelid retraction because they explore innovative materials for spacer grafts, which are crucial in eyelid repair. The use of autologous ear cartilage is promising because it leverages the patient’s own tissue, potentially reducing rejection risks. Hard palate grafts are another option, offering structural strength due to their dense composition. Meanwhile, porcine acellular dermal matrix introduces a novel approach by using a biocompatible tissue scaffold that can integrate seamlessly with human tissue. These varied approaches aim to enhance outcomes compared to traditional methods like synthetic implants or other graft materials.

What evidence suggests that this trial's spacer graft treatments could be effective for lower eyelid retraction?

This trial will compare different spacer graft materials for lower eyelid retraction repair. Research has shown that using a patient's own ear cartilage, one option in this trial, effectively repairs lower eyelid retraction, yielding good results with few complications. Another option is hard palate grafts, which use tissue from the roof of the mouth and also deliver predictable, satisfactory outcomes. These grafts have a complication rate of about 10%, considered manageable. The trial will also evaluate porcine acellular dermal matrix, a type of bioengineered tissue from pigs, which is safe and effective, providing a reliable alternative to using the patient's own tissue. Each of these options has proven effective in correcting eyelid retraction. ^{1 2 3 6 7}

Who Is on the Research Team?

Anne Barmettler, MD

Principal Investigator

Director of Oculoplastic Surgery Division

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had surgery to fix lower eyelid drooping using a spacer graft between July 1, 2019, and July 1, 2022.

Exclusion Criteria

I have not had, nor do I need, any other eye surgeries within 6 months after my eyelid operation.

Patients without postoperative 6-month data will be excluded from the postoperative month 6 MRD2 calculation.

Patients with less than 1-month follow up will be excluded from all outcome analysis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lower eyelid retraction repair with randomized spacer grafts (autologous ear cartilage, hard palate, or porcine acellular dermal matrix)

1 week

1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes and post-surgical complications

6 months

4 visits (in-person) at 1 week, 1 month, 3 months, and 6 months post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Spacer Graft

Trial Overview 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).

How Is the Trial Designed?

Group I: Porcine Acellular Dermal Matrix Experimental Treatment 1 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

Group II: Hard Palate Experimental Treatment 1 Intervention

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

Group III: Autologous Ear Cartilage Experimental Treatment 1 Intervention

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

Spacer Graft is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spacer Graft for:

• Lower Eyelid Retraction Repair

Approved in European Union as Spacer Graft for:

• Lower Eyelid Retraction Repair
• Eyelid Reconstruction

Approved in Canada as Spacer Graft for:

• Lower Eyelid Retraction Repair

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

In a study involving 49 lower eyelids from 39 patients, three types of spacer grafts (autologous auricular cartilage, bovine acellular dermal matrix, and porcine acellular dermal matrix) were compared for lower eyelid retraction repair, showing no statistically significant differences in overall outcomes after 6 months.

Postoperative swelling was significantly higher in the group receiving auricular cartilage compared to the other graft types at one week, but this did not translate into long-term differences in eyelid function or comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized Comparison of Lower Eyelid Retraction Repair With Autologous Auricular Cartilage, Bovine Acellular Dermal Matrix (Surgimend), and Porcine Acellular Dermal Matrix (Enduragen) Spacer Grafts. Barmettler, A., Heo, M.[2018]

The use of hard palate mucosal grafts as spacers has shown excellent success in correcting lower eyelid retraction after orbital fracture repairs, addressing both functional and cosmetic issues.

This technique involves releasing scar tissue and repositioning the eyelid, leading to improved outcomes in patients with contracted lower eyelid retractors and lateral canthal tendon tightening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of hard palate grafts for treatment of postsurgical lower eyelid retraction: a technical overview. Patipa, M., Patel, BC., McLeish, W., et al.[2004]

In a study involving 69 patients and 129 eyelids, the new acellular porcine dermal graft (Enduragen) demonstrated a 10% complication rate, with infections successfully treated using antibiotics, indicating its safety in eyelid surgeries.

Enduragen was found to be a reliable alternative to traditional materials like ear cartilage and fascia, providing comparable strength and support in both reconstructive and aesthetic eyelid procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of porcine acellular dermal matrix (Enduragen) grafts in eyelids: a review of 69 patients and 129 eyelids. McCord, C., Nahai, FR., Codner, MA., et al.[2021]

In a study involving 18 patients with lower eyelid retraction, using hard-palate mucosa as a spacer graft resulted in predictable and satisfactory outcomes for 25 eyelids.

The hard-palate mucosa was easy to obtain, and the donor site healed well with minimal care required, indicating a safe and effective method for managing lower eyelid retraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of lower-lid retraction with hard-palate mucosa grafting. Kersten, RC., Kulwin, DR., Levartovsky, S., et al.[2019]

The Medpor lower eyelid spacer (LES) was effective in improving eyelid position and reducing symptoms like lagophthalmos in 32 patients over an average follow-up of 22 months, showing significant improvements in eyelid measurements.

However, the procedure had a notable complication rate, with major complications in 7 out of 32 patients, suggesting that while it can be beneficial, it should be considered primarily for patients who cannot undergo safer alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of porous polyethylene (Medpor) lower eyelid spacers in lid heightening and stabilisation. Tan, J., Olver, J., Wright, M., et al.[2018]

In a study of 25 eyelids from 23 patients, both autologous dermis grafts and conchal cartilage grafts were found to effectively reduce inferior scleral show (ISS) without significant differences in outcomes such as lagophthalmos or corneal keratitis.

Both graft types resulted in favorable outcomes with low complication rates, indicating that either option is a safe and effective choice for lower eyelid lengthening procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous dermis graft versus conchal cartilage graft for managing lower eyelid retraction: A comparative study. Martel, A., Farah, E., Zmuda, M., et al.[2022]

In a study of 12 patients who underwent a combined surgical technique for cicatricial lower eyelid retraction and entropion, all patients experienced resolution of entropion and significant improvement in eyelid retraction, with an average elevation of 2.93 mm.

The surgical approach, which included scar release, hard palate grafting, and lateral canthal tightening, resulted in stable long-term outcomes and low complication rates, enhancing both ocular surface symptoms and cosmetic appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction of Cicatricial Lower Eyelid Retraction and Entropion With Combined Scar Release, Hard Palate Graft, and Lateral Canthal Suspension. Zhang, Z., Yanjun, S., Ye, X.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04140734

Study Details | NCT04140734 | Spacer Graft Study A Prospective, Randomized Comparison of Lower Eyelid Retraction Repair With Autologous Auricular Cartilage, Bovine Acellular Dermal Matrix (Surgimend), and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38965129/

Lower eyelid retraction repair using autologous auricular ... Purpose: To assess the efficacy of lower eyelid retraction surgery utilizing autologous auricular scapha cartilage (located within the anterior ...

3. academic.oup.com academic.oup.com/asj/article/37/7/743/3061143

Comparison of Efficacy and Complications Among Various ... The authors reviewed the currently available evidence to determine the best available spacer graft material in terms of efficacy and complications.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28658181/

A Prospective, Randomized Comparison of Lower Eyelid ... Purpose: To compare outcomes of lower eyelid retraction repair with 3 types of spacer grafts: autologous auricular cartilage, bovine acellular dermal matrix ( ...

5. aaojournal.org aaojournal.org/article/S0161-6420(19)32291-2/fulltext

Bioengineered Acellular Dermal Matrix Spacer Grafts for ... To review the literature on the efficacy and safety of bioengineered acellular dermal matrix (BADM) grafts for lower eyelid retraction repair.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1742706124001624

Bioengineering autologous cartilage grafts for functional ... In this study, we utilized autologous auricular chondrocyte-based TEC grafts for posterior lamellar eyelid reconstruction in a preclinical ...

7. aaojournal.org aaojournal.org/article/S0161-6420(19)32291-2/pdf

Bioengineered Acellular Dermal Matrix Spacer Grafts for ... In a prospective, randomized trial, Barmettler and Heo3 compared outcomes of lower eyelid retraction repair in 3 study groups, each using a ...