Use of Non-Cadaveric Human Acellular Dermal Tissue (BellaDerm®) in Lower Eyelid Retraction Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Eyelid Retraction
- Sponsor
- SGM Physician Research Consortium
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Pre and Post operative margin reflex distance 2 MRD 2
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.
Detailed Description
To Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.
Investigators
Kenneth Morgenstern, MD
Kenneth Morgenstern, MD
SGM Physician Research Consortium
Eligibility Criteria
Inclusion Criteria
- •Lower eyelid retraction, defined as inferior displacement of the lower eyelid margin with inferior scleral show, may be asymptomatic
- •May have ocular irritation including foreign body sensation, burning, photophobia and tearing.
- •May have aesthetically unsatisfactory eyelid appearance.
Exclusion Criteria
- •Have a condition that would be contraindicated to surgery
Outcomes
Primary Outcomes
Pre and Post operative margin reflex distance 2 MRD 2
Time Frame: 1 year
Pre and postoperative margin reflex distance 2 (MRD2) and inferior scleral show (ISS) was measured of each eyelid, and success was defined as a positive eyelid elevation and decrease in inferior scleral show. Long- term stability beyond 12 months was evaluated.