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The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation.
Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored.
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DALK using Dehydrated Corneas | Experimental | Corneal transplantation of anterior lamellar grafts from dehydrated corneas. |
|
| DALK using Standard Organ Culture Stored Corneas | Active Comparator | Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep anterior lamellar keratoplasty | Procedure | Deep anterior lamellar keratoplasty using dehydrated corneas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in best spectacle-corrected visual acuity | Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart | Preoperatively; and 6 and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in astigmatism | Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA) | Preoperatively; and 6 and 12 months postoperatively |
| Change in Thinnest-point pachymetry |
| Measure | Description | Time Frame |
|---|---|---|
| Refraction | Measured by manifest refraction | 6 and 12 months postoperatively |
| Adverse Events/Complication | Comparison of total rates of adverse events/complications assessed clinically |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo Busin, MD | Contact | +393473448343 | mbusin@yahoo.com | |
| Angeli Christy Yu, MD | Contact | +393663903896 | angeliyu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Busin, MD | UniversitĂ degli Studi di Ferrara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Privati Forlì "Villa Igea" | Recruiting | Forlì | Emilia-Romagna | 47122 | Italy |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| Deep anterior lamellar keratoplasty | Procedure | Deep anterior lamellar keratoplasty using standard organ culture stored corneas |
|
Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)
| Preoperatively; and 6 and 12 months postoperatively |
| Change in endothelial cell density | Measured using noncontact specular microscopy | Preoperatively; and 6 and 12 months postoperatively |
| Incidence of graft rejection | Clinically assessed during postoperative examinations | 6 and 12 months postoperatively |
| Incidence of graft failure | Clinically assessed during postoperative examinations | 6 and 12 months postoperatively |
| Corneal donor loss due to preparation | Based on intraoperative assessment of corneas unusable for corneal transplantation | Intraoperative |
| up to 12 months postoperatively |