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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133495

Enrollment

Registered

2014-05-08

Start date

2011-01-31

Completion date

2014-01-31

Last updated

2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Eyelid Retraction

Keywords

lower eyelid, retraction

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.

Interventions

PROCEDURENon Cadaveric Human Acellular Dermal Tissue

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Inferior scleral show	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026