Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- best corrected visual acuity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
closed PKP under topical anesthesia
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
干预措施: closed PKP under topical anesthesia (Procedure)
closed PKP under topical anesthesia
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
干预措施: Anti-Rejection Agents (Drug)
closed PKP under topical anesthesia
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
干预措施: Anti-Inflammatory Agents (Drug)
open-sky PKP under retrobulbar anesthesia
an open-sky corneal transplantation under retrobulbar anesthesia
干预措施: open-sky PKP under retrobulbar anesthesia (Procedure)
open-sky PKP under retrobulbar anesthesia
an open-sky corneal transplantation under retrobulbar anesthesia
干预措施: Anti-Rejection Agents (Drug)
open-sky PKP under retrobulbar anesthesia
an open-sky corneal transplantation under retrobulbar anesthesia
干预措施: Anti-Inflammatory Agents (Drug)
Anti-Rejection Agents
Anti-Rejection Agents for both groups
干预措施: closed PKP under topical anesthesia (Procedure)
Anti-Rejection Agents
Anti-Rejection Agents for both groups
干预措施: open-sky PKP under retrobulbar anesthesia (Procedure)
Anti-Inflammatory Agents
Anti-Inflammatory Agents for both groups
干预措施: closed PKP under topical anesthesia (Procedure)
Anti-Inflammatory Agents
Anti-Inflammatory Agents for both groups
干预措施: open-sky PKP under retrobulbar anesthesia (Procedure)
结局指标
主要结局
best corrected visual acuity
时间窗: 6 months after PKP
次要结局
- Endothelial cell density(6 months after PKP)
研究者
Jinyang Li
PhD
Wenzhou Medical University