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临床试验/CTRI/2026/02/102658
CTRI/2026/02/102658尚未招募不适用

Assessment of Efficacy of Peribulbar Anesthesia for Therapeutic Keratoplasty and the Risk Factors associated with Poor Intraoperative Anesthesia for Therapeutic Penetrating Keratoplasty and its Outcomes

Aravind Eye Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
1. Number of patients having poor intraoperative analgesia

研究概览

简要总结

Therapeutic penetrating keratoplasty is a corneal transplant procedure performed to treat non-healing corneal ulcers and corneal ulcers with perforation with an aim to eliminate the infective foci and maintain the integrity of the globe. This complex surgery typically lasts between 30 minutes and 1.5 hours. The type of anesthesia used for therapeutic keratoplasty can vary, ranging from local anesthesia (such as retrobulbar, peribulbar, or sub-tenon anesthesia) to general anesthesia.1 Some case series have also reported performing penetrating keratoplasty under topical anesthesia with sedation in situations where local and general anesthesia were contraindicated.2

During penetrating keratoplasty, the eye is kept open for a brief period following removal of the diseased host tissue until placement of the donor corneal tissue, which increases the risk of positive vitreous pressure (PVP).  PVP is associated with lens expulsion, posterior capsular rupture, vitreous loss and devastating suprachoroidal expulsive hemorrhage.3

Poor ophthalmic anesthesia results in incomplete akinesia and inadequate analgesia which are independent risk factors for PVP. This is followed by lack of patient co-operation, intra-operative anxiety and continuation of surgery difficult. Intraoperative anxiety can precipitate systemic complications like pulmonary edema, cardiac crisis or a stroke. In this study, we aim to analyze the efficacy of peribulbar anesthesia in therapeutic penetrating keratoplasty and the ocular risk factors associated with poor anesthesia and its clinical outcomes

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Corneal ulcers of any etiology requiring therapeutic penetrating keratoplasty
  • Patients with prior history of Therapeutic keratoplasty requiring repeat therapeutic keratoplasty for graft re- infection or graft melt.

排除标准

  • Patients undergoing cosmetic or optical penetrating keratoplasty
  • Patients with Cognitive impairment
  • Deaf and Mute patients
  • Pregnant and Lactating women
  • Patients on long term anxiolytic agents / other Psychiatric illness
  • Patients who lacked insight and unwilling to participate in the study.
  • Patients requiring general anesthesia for Therapeutic penetrating keratoplasty.

结局指标

主要结局

1. Number of patients having poor intraoperative analgesia

时间窗: Baseline. Outcome measures are assessed intra-operatively. There are no follow-ups

2. Number of patients developing intraoperative complications during therapeutic keratoplasty

时间窗: Baseline. Outcome measures are assessed intra-operatively. There are no follow-ups

3. Number of patients requiring repeat intra-operative local anesthesia

时间窗: Baseline. Outcome measures are assessed intra-operatively. There are no follow-ups

次要结局

未报告次要终点

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Naveen Radhakrishnan

Aravind Eye Hospital

研究点 (1)

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