Spacer Graft Study

Conditions

• Eyelid Diseases
• Eyelid Droop

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.

Study Details

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)

Key Dates

Start date

Aug 1, 2021

Status verified

Apr 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Hard Palate
  Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate
• Experimental: Autologous Ear Cartilage
  Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage
• Experimental: Porcine Acellular Dermal Matrix
  Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix

Primary Outcome Measure

Lower Eyelid Height [ Time Frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively ]

Central Contacts

• Anne Barmettler, MD
  (978) 886-7122
  [email protected]

Locations (1)

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