Spacer Graft Study

NCT04140734 | Recruiting DMC FDA Device

• 1 other identifier: 2019-10410
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Eyelid Diseases; Eyelid Droop

Keywords

Retraction Repair; Hard Palate; Autologous Ear Cartilage; porcine acellular dermal matrix; spacer graft

Outcome Measures

Primary Outcomes (1)

• Lower Eyelid Height

  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.

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

Secondary Outcomes (1)

• Post-Surgical Complications

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

Study Arms (3)

Hard Palate

EXPERIMENTAL

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

Autologous Ear Cartilage

EXPERIMENTAL

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

Porcine Acellular Dermal Matrix

EXPERIMENTAL

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

Interventions

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.

Autologous Ear Cartilage; Hard Palate; Porcine Acellular Dermal Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (5)

• Bartley GB. The differential diagnosis and classification of eyelid retraction. Ophthalmology. 1996 Jan;103(1):168-76. doi: 10.1016/s0161-6420(96)30744-6.

  PMID: 8628549 BACKGROUND

• Baylis HI, Nelson ER, Goldberg RA. Lower eyelid retraction following blepharoplasty. Ophthalmic Plast Reconstr Surg. 1992;8(3):170-5. doi: 10.1097/00002341-199209000-00002.

  PMID: 1390423 BACKGROUND

• Barmettler A, Heo M. 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. Ophthalmic Plast Reconstr Surg. 2018 May/Jun;34(3):266-273. doi: 10.1097/IOP.0000000000000946.

  PMID: 28658181 BACKGROUND

• Wearne MJ, Sandy C, Rose GE, Pitts J, Collin JR. Autogenous hard palate mucosa: the ideal lower eyelid spacer? Br J Ophthalmol. 2001 Oct;85(10):1183-7. doi: 10.1136/bjo.85.10.1183.

  PMID: 11567962 BACKGROUND

• Liao YL, Wu SY, Tsai YJ. Long-Term Results of Autologous Auricular Cartilage Graft Applied in Anophthalmic Orbits Unable to Wear Prosthesis. J Ophthalmol. 2019 Apr 9;2019:7197063. doi: 10.1155/2019/7197063. eCollection 2019.

  PMID: 31093371 BACKGROUND

MeSH Terms

Conditions

Eyelid Diseases; Blepharoptosis

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Anne Barmettler, MD

  Director of Oculoplastic Surgery Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Barmettler, MD

CONTACT

(978) 886-7122; abarmett@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: August 1, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)