Corneal Opacity, Keratitis, Herpetic, Corneal Ulcer, Corneal Dystrophies, Hereditary
Conditions
Brief summary
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.
Interventions
PROCEDUREclosed PKP under topical anesthesia
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
PROCEDUREopen-sky PKP under retrobulbar anesthesia
an open-sky corneal transplantation under retrobulbar anesthesia
DRUGAnti-Rejection Agents
Anti-Rejection Agents for both groups
Anti-Inflammatory Agents for both groups
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* active bacterial keratitis, for which ulceration progressed despite maximum antibacterial medication; * refractory fungal keratitis that did not respond to antifungal agents; * nonactive HSK, for which corneal opacities with or without new vessels involved the optical zone; * ocular acid burn and thermal burn with partial limbal deficiency (50% or less) that, after more than half a year of preoperative treatment, showed reepithelialization and less than 2 quadrants limbal neovascularization.
Exclusion criteria
* Patients with keratolimbal allograft transplantation, total limbal stem cell deficiency secondary to ocular burns, and other ocular diseases (ie, amblyopia, age-related cataract, glaucoma, macular edema, and mac ular degeneration) were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best corrected visual acuity | preoperative |
Secondary
| Measure | Time frame |
|---|---|
| Endothelial cell density | 1 week after PKP |
Countries
China
Outcome results
None listed