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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lower Eyelid Retraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open label

Non Cadaveric human BellaDerm Acellular dermal tissue

Group Type EXPERIMENTAL

Non Cadaveric Human Acellular Dermal Tissue

Intervention Type PROCEDURE

Interventions

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Non Cadaveric Human Acellular Dermal Tissue

Intervention Type PROCEDURE

Other Intervention Names

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Bella Derm

Eligibility Criteria

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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.