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| Name | Class |
|---|---|
| Beauty of Sight | UNKNOWN |
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The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRGF group | Experimental | Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year. |
|
| Control group | Active Comparator | Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endothelial keratoplasty | Procedure | Surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea) with brief incubation of the donor tissue in PRGF prior to graft implantation. This incubation will be a one time procedure done to the tissue in the operating room. The endothelial keratoplasty is 30-45 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in endothelial cell percentage | Central corneal endothelial cell percentage will be assessed by specular microscopy and compared with the baseline donor endothelial cell percentage measured by the provider eye bank to determine endothelial cell changes. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal endothelial cell density | Central corneal endothelial cell density by specular microscopy (cells/millimeter^2) | Up to 12 months |
| Change in Endothelial cell density | Change in central corneal endothelial cell density will be assessed by specular microscopy (cells/millimeter^2) and compared with the baseline donor endothelial cell density reported by the provider eye bank to determine endothelial cell loss |
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Inclusion Criteria:
Exclusion Criteria:
The following special populations will be excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alfonso L Sabater, MD | Contact | 3053266326 | asabater@med.miami.edu | |
| Marianne Price, PhD | Contact | 317-814-2990 | mprice@cornea.org |
| Name | Affiliation | Role |
|---|---|---|
| Alfonso L Sabater, MD | Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Recruiting | Miami | Florida | 33136 | United States |
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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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| PRGF | Biological | Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient. PRGF incubation lasts 15 minutes. It is a one-time procedure performed on the tissue that will be done in the operating room prior to endothelial keratoplasty. |
|
| Baseline, up to 12 months |
| Visual acuity measured by snellen chart | Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart. | Up to 12 months |
| Number of re-bubbling for graft attachment | The number of air re-injections for graft attachment within the first 2 months will be assessed. | Up to 2 months |
| Price Vision Group | Recruiting | Indianapolis | Indiana | 46260 | United States |
|
| 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 |