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NCT Number: NCT04140734

Spacer Graft Study

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location status: Recruiting

About this study

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. 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. 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. As of now, surgery with any of the spacer grafts, including autologous hard palate, is accepted as standard of care.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Spacer Graft

Device

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 outcomes

  1. Lower Eyelid Height

    Time frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively

    Lower Eyelid Height will be measured via Margin Reflect Distance 2 (MRD2). Photographs taken during study visits will analyze 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. Results will be summarized and reported by study arm using basic descriptive statistics. A normal MRD2 is about 4. The higher the number for MRD2, the more severe the retraction. Postoperatively, a lower MRD2 indicates a better surgical outcome.

Secondary outcomes

  1. Post-Surgical Complications

    Time frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively

    Post-Surgical Complications will be summarized using specific complications as graded by either the examiner or the patient. Specifically, conjunctival injection and eyelid swelling will be graded by the examiner on a scale of 0 to 10 where "0" indicates no visible injection or swelling (normal), respectively and "10" is indicative of the most severe level of conjuctival redness or swelling, respectively. Similarly, tearing, itching, and discomfort will be individually graded by the patient on a scale of 0-10 wherein "0" is indicative of no tearing, itching, or discomfort, respectively and "10" is indicative of maximal tearing, itching, and discomfort, respectively. Results will be summarized and reported by study arm using basic descriptive statistics.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Barmettler, MD

CONTACT

[email protected]

(978) 886-7122

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 28, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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