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| Name | Class |
|---|---|
| Musculoskeletal Transplant Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Experimental | Non Cadaveric human BellaDerm Acellular dermal tissue |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Cadaveric Human Acellular Dermal Tissue | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Inferior scleral show | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morgenstern Center for Orbital and Facial Plastic Surgery | Wayne | Pennsylvania | 19087 | United States |
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