An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair

Not Applicable

Completed

• Conditions: Lower Eyelid Retraction
• Interventions: Procedure: Non Cadaveric Human Acellular Dermal Tissue

• Registration Number: NCT02133495
• Lead Sponsor: SGM Physician Research Consortium

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-01
• Study Completion: 2014-01
• Status Verified: 2014-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Study First Posted: 2014-05-08
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label	Non Cadaveric Human Acellular Dermal Tissue	Non Cadaveric human BellaDerm Acellular dermal tissue

Primary Outcome Measures

Name	Time	Method
Pre and Post operative margin reflex distance 2 MRD 2	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.

Trial Locations

Locations (1)

Morgenstern Center for Orbital and Facial Plastic Surgery; 🇺🇸 Wayne, Pennsylvania, United States