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Penetrating keratoplasty (PKP) is an open-sky surgery that fundamentally has not changed for more than 100 years. Because conventional PKP is associated with the potential for the development of devastating complications such as expulsive suprachoroidal hemorrhage and endophthalmitis, we modified the technique to one that is a closed surgery under topical anesthesia with the anterior chamber maintained to achieve favorable results. Topical anesthesia is an attractive alternative to traditional injection local anesthesia since the potentially serious complications associated with retrobulbar and peribulbar anesthesia can be avoided. The closed PKP procedure with the stable anterior chamber essentially changes the open nature of conventional PKP. The advantages, i.e., decreased surgical risks, postoperative complications, and surgical difficulties, make PKP viable in most complicated cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| closed PKP under topical anesthesia | Experimental | a closed corneal transplantation under topical anesthesia with the anterior chamber maintained |
|
| open-sky PKP under retrobulbar anesthesia | Active Comparator | an open-sky corneal transplantation under retrobulbar anesthesia |
|
| Anti-Rejection Agents | Other | Anti-Rejection Agents for both groups |
|
| Anti-Inflammatory Agents | Other | Anti-Inflammatory Agents for both groups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| closed PKP under topical anesthesia | Procedure | a closed corneal transplantation under topical anesthesia with the anterior chamber maintained |
|
| Measure | Description | Time Frame |
|---|---|---|
| best corrected visual acuity | preoperative | |
| best corrected visual acuity | 1 week after PKP | |
| best corrected visual acuity | 2 weeks after PKP | |
| best corrected visual acuity | 1 month after PKP | |
| best corrected visual acuity | 3 months after PKP | |
| best corrected visual acuity | 6 months after PKP |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell density | 1 week after PKP | |
| Endothelial cell density | 2 weeks after PKP | |
| Endothelial cell density |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Hospital, Wenzhou Medical College | Recruiting | Wenzhou | Zhejiang | 325027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23860425 | Background | Chen W, Ren Y, Zheng Q, Li J, Waller SG. Securing the anterior chamber in penetrating keratoplasty: an innovative surgical technique. Cornea. 2013 Sep;32(9):1291-5. doi: 10.1097/ICO.0b013e31829954c5. |
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| open-sky PKP under retrobulbar anesthesia | Procedure | an open-sky corneal transplantation under retrobulbar anesthesia |
|
| Anti-Rejection Agents | Drug | Anti-Rejection Agents for both groups |
|
| Anti-Inflammatory Agents | Drug | Anti-Inflammatory Agents for both groups |
|
| 1 month after PKP |
| Endothelial cell density | 3 months after PKP |
| Endothelial cell density | 6 months after PKP |
| ID | Term |
|---|---|
| D003318 | Corneal Opacity |
| D016849 | Keratitis, Herpetic |
| D003320 | Corneal Ulcer |
| D003317 | Corneal Dystrophies, Hereditary |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007634 | Keratitis |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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