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

May 7, 2014 updated by: Kenneth Morgenstern, MD, SGM Physician Research Consortium

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wayne, Pennsylvania, United States, 19087
        • Morgenstern Center for Orbital and Facial Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: open label
Non Cadaveric human BellaDerm Acellular dermal tissue
Procedure: Non Cadaveric Human Acellular Dermal Tissue
Other Names:
  • Bella Derm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SGM Physician Research Consortium

Collaborators

Musculoskeletal Transplant Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMBella1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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