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

SGM Physician Research Consortium

Status: Completed

Conditions: Lower Eyelid Retraction

Treatments: Procedure: Non Cadaveric Human Acellular Dermal Tissue

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02133495

KMBella1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

open label

Experimental group

Description:

Non Cadaveric human BellaDerm Acellular dermal tissue

Treatment:

Procedure: Non Cadaveric Human Acellular Dermal Tissue