Spacer Grafts for Lower Eyelid Retraction

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

Trial Summary

What is the purpose of this trial?

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)

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 data supports the effectiveness of the treatment Spacer Graft for Lower Eyelid Retraction?

Research shows that using hard palate grafts and autologous ear cartilage grafts as spacer materials can effectively correct lower eyelid retraction, leading to satisfactory cosmetic and functional results. Studies have demonstrated that these grafts help reposition the eyelid to its normal position and heal well with minimal care. ^{1 2 3 4 5}

Is the use of spacer grafts for lower eyelid retraction safe?

Spacer grafts, including those made from hard palate tissue, ear cartilage, and porcine dermal matrix (Enduragen), have been used in various studies for lower eyelid retraction with generally positive safety outcomes. The donor sites for hard palate grafts healed well with minimal care, and the use of Enduragen in 129 eyelids showed promising results, indicating these materials are generally safe for human use. ^{2 3 4 6 7}

How is the Spacer Graft treatment unique for lower eyelid retraction?

The Spacer Graft treatment for lower eyelid retraction is unique because it uses materials like hard palate mucosa, autologous ear cartilage, and acellular dermal matrices from animals to support and reposition the eyelid. These materials are chosen for their ability to integrate well with the body and provide a stable, long-lasting correction of the eyelid position. ^{1 2 3 4 5}

Research Team

Anne Barmettler, MD

Principal Investigator

Director of Oculoplastic Surgery Division

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Correction of Cicatricial Lower Eyelid Retraction and Entropion With Combined Scar Release, Hard Palate Graft, and Lateral Canthal Suspension. [2023]

2. United States 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Use of hard palate grafts for treatment of postsurgical lower eyelid retraction: a technical overview. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Management of lower-lid retraction with hard-palate mucosa grafting. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Autologous dermis graft versus conchal cartilage graft for managing lower eyelid retraction: A comparative study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The use of porous polyethylene (Medpor) lower eyelid spacers in lid heightening and stabilisation. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Use of porcine acellular dermal matrix (Enduragen) grafts in eyelids: a review of 69 patients and 129 eyelids. [2021]