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Completed

NCT Number: NCT02133495

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

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.

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Key information

Conditions

Lower Eyelid Retraction

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Morgenstern Center for Orbital and Facial Plastic Surgery

Wayne, Pennsylvania, 19087, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non Cadaveric Human Acellular Dermal Tissue

Procedure

Other names: Bella Derm

Primary outcomes

  1. 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.

Other outcomes

  1. Inferior scleral show

    Time frame: 1 year

    Pre and post operative margin reflex distance 2 (MRD2) and inferior scleral show (ISS) where measured for each eyelid elevation and decrease in inferior scleral show.

Sponsors and collaborators

Lead sponsor

SGM Physician Research Consortium

Network

Collaborators

  • Musculoskeletal Transplant Foundation

Registry information

Official study title

Use of Non-Cadaveric Human Acellular Dermal Tissue (BellaDerm®) in Lower Eyelid Retraction Repair

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
May 8, 2014
Registry last updated
May 8, 2014

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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