Lower Eyelid RetractionNCT02133495
An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair
A study testing Non Cadaveric Human Acellular Dermal Tissue in people with Lower Eyelid Retraction, run by SGM Physician Research Consortium at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Lower Eyelid Retraction
- What is being tested?
- Non Cadaveric Human Acellular Dermal Tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have a condition that would be contraindicated to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgenstern Center for Orbital and Facial Plastic Surgery
Wayne, Pennsylvania, 19087
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Eyelid Retraction
- Being tested
- Non Cadaveric Human Acellular Dermal Tissue
- Keywords
- lower eyelid, retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Cadaveric Human Acellular Dermal TissueProcedure or surgery
Also called Bella Derm
| Study group | Role | What they receive |
|---|---|---|
| open label | Experimental | Non Cadaveric human BellaDerm Acellular dermal tissue Receives: Procedure: Non Cadaveric Human Acellular Dermal Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Eyelid RetractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- SGM Physician Research Consortium
- Sponsor type
- Research network
- Collaborators
- Musculoskeletal Transplant Foundation
- Responsible party
- Principal investigator, Kenneth Morgenstern, MD, SGM Physician Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133495
- Sponsor's protocol ID
- KMBella1
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Non-Cadaveric Human Acellular Dermal Tissue (BellaDerm®) in Lower Eyelid Retraction Repair
- ClinicalTrials.gov ID
- NCT02133495
- Acronym / sponsor ID
- KMBella1
- Conditions
- Lower Eyelid Retraction
- Keywords
- lower eyelid, retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SGM Physician Research ConsortiumResearch network
- Collaborators
- Musculoskeletal Transplant Foundation
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Experimental | Procedure: Non Cadaveric Human Acellular Dermal TissueNon Cadaveric human BellaDerm Acellular dermal tissue |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Have a condition that would be contraindicated to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Cadaveric Human Acellular Dermal TissueAlso: Bella Derm | Procedure or surgery | open label |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
Related trials for Lower Eyelid Retraction
Recruiting
Spacer Graft Study
Eyelid Diseases, Eyelid Droop
Recruiting
Acellular Dermal Matrix vs Autologous Tarsus for Correction of Lower Eyelid Retraction
Lower Eyelid Retraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Cadaveric Human Acellular Dermal Tissue in people with Lower Eyelid Retraction, run by SGM Physician Research Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre and Post operative margin reflex distance 2 MRD 2 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.