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| Name | Class |
|---|---|
| North Carolina Lion's Eye Bank | UNKNOWN |
| Price Vision Group | INDUSTRY |
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Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. |
|
| 2 | Active Comparator | The surgeon dissected the donor grafts used for the transplant procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descemet's stripping endothelial keratoplasty | Procedure | Small incision corneal transplant procedure to treat dysfunctional endothelium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Cell Loss | Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100. | 6 months after grafting |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Vision | 6 months and 1 year after grafting | |
| Graft Dislocation | 1 day to 1 month after grafting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis W Price, Jr, MD | Cornea Research Foundation of America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea Research Foundation of America | Indianapolis | Indiana | 46260 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eye Bank Pre-cut Grafts | An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. |
| FG001 | Surgeon Dissected Grafts | The surgeon dissected the donor grafts used for the transplant procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eye Bank Pre-cut Grafts | An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. |
| BG001 | Surgeon Dissected Grafts | The surgeon dissected the donor grafts used for the transplant procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Endothelial Cell Loss | Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100. | Posted | Mean | Standard Deviation | percentage of endothelial cell loss | 6 months after grafting |
|
1 year
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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 | Eye Bank Pre-cut Grafts | An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| graft dislocation and reattachment | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne O. Price, PhD | Cornea Research Foundation of America | 317-814-2990 | mprice@cornea.org |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| ID | Term |
|---|---|
| D057111 | Descemet Stripping Endothelial Keratoplasty |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Best Corrected Vision | Not Posted | 6 months and 1 year after grafting |
| Secondary | Graft Dislocation | Not Posted | 1 day to 1 month after grafting |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Surgeon Dissected Grafts | The surgeon dissected the donor grafts used for the transplant procedures. | 0 | 20 | 2 | 20 |
| graft rejection episode | Eye disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016039 |
| Corneal Transplantation |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |