NCT02133495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

May 6, 2014

Last Update Submit

May 7, 2014

Conditions

Lower Eyelid Retraction

Keywords

lower eyelidretraction

Outcome Measures

Primary Outcomes (1)

  • Pre and Post operative margin reflex distance 2 MRD 2

    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 Outcomes (1)

  • Inferior scleral show

    1 year

Study Arms (1)

open label

EXPERIMENTAL

Non Cadaveric human BellaDerm Acellular dermal tissue

Procedure: Non Cadaveric Human Acellular Dermal Tissue

Interventions

Non Cadaveric Human Acellular Dermal TissuePROCEDURE
Also known as: Bella Derm
open label

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have a condition that would be contraindicated to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morgenstern Center for Orbital and Facial Plastic Surgery

Wayne, Pennsylvania, 19087, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kenneth Morgenstern, MD

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

US(1)