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Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Active Comparator | prospective arm receiving cryopreserved amniotic membrane |
|
| Control | No Intervention | Retrospective review of debridement without cryopreserved amniotic membrane |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryopreserved amniotic membrane | Device | placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Lens Calculation | Assessed by corneal topography | Change from Baseline to 1 month |
| Change in Intraocular Lens Power Calculation | Assessed using biometry and calculated using Holladay I formula | Change from Baseline to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Yeu, MD | Virginia Eye Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Retrospective review of debridement without cryopreserved amniotic membrane |
| FG001 | Study | prospective arm receiving cryopreserved amniotic membrane cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for epithelial basement membrane dystrophy (EBMD) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study | prospective arm receiving cryopreserved amniotic membrane cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intraocular Lens Calculation | Assessed by corneal topography | Posted | Mean | Standard Deviation | D | Change from Baseline to 1 month |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | prospective arm receiving cryopreserved amniotic membrane cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Medical Affairs | TissueTech | 8882968858 | hsheha@tissuetechinc.com |
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| ID | Term |
|---|---|
| C535477 | Corneal dystrophy, epithelial basement membrane |
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Retrospective review of debridement without cryopreserved amniotic membrane
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Intraocular Lens Power Calculation | Assessed using biometry and calculated using Holladay I formula | Posted | Mean | Standard Deviation | D | Change from Baseline to 1 month |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | Retrospective review of debridement without cryopreserved amniotic membrane | 0 | 10 | 0 | 10 |
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