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临床试验/CTRI/2026/01/102619
CTRI/2026/01/102619招募中不适用

Corneal Donor and Patient Related Factors Influencing Graft Infection in Therapeutic Keratoplasty: A clinical, surgical and microbiological Analysis

Aravind Eye Hospital and Postgraduate Institute of Ophthalmology1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2026年2月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
138
试验地点
1

研究概览

简要总结

Therapeutic keratoplasty (TPK) is a surgical procedure used to treat advanced, refractory microbial keratitis, due to failed medical management, and perforation. TPK is the last resort to remove the infected tissue and replace it with a healthy donor cornea. The primary goal of TPK is to eliminate the active infectious process, restore the structural integrity of the globe, and prevent complications such as phthisis bulbi and endophthalmitis. In regions where microbial keratitis is more prevalent, particularly in developing countries, TPK is frequently performed to address refractory or advanced bacterial, fungal, and parasitic corneal infections.

However, therapeutic keratoplasty is associated with significant challenges despite its critical role in halting disease progression. Postoperative complications, such as graft infection pose substantial risks to the success of the procedure, which may lead to corneal melt, secondary glaucoma, anatomical failure, anterior staphyloma, and phthisis bulbi. Fungal keratitis has been shown to have higher recurrence rates compared to bacterial infections, complicating the management of these patients. TPK requires not only precise surgical intervention but also meticulous postoperative care to minimise complications and ensure the long-term viability of the graft.

There are several notable research gaps in the current understanding of TPK outcomes. First, there is limited knowledge regarding the specific causes of infection recurrence, particularly in cases involving fungal keratitis. Preoperative conditions, such as corneal perforation and the presence of hypopyon, have been implicated as risk factors, but the exact mechanisms remain unclear. Second, the quality of donor material used in TPK can vary significantly, particularly in resource-limited settings where high-quality corneas are scarce. Finally, there is a need for standardised postoperative antimicrobial protocols. While prophylactic antiviral treatments are well-established for viral keratitis, optimal regimens for bacterial and fungal infections remain inconsistent across institutions.

Addressing these research gaps is crucial to improving the outcomes of therapeutic keratoplasty. Understanding the causes of graft infection could lead to more effective preoperative risk assessments and targeted interventions. Further investigation into the impact of donor cornea quality would provide valuable insights into optimising donor selection and tissue preservation techniques. Additionally, research focused on developing standardised postoperative antimicrobial protocols would help reduce the variability in treatment outcomes and improve overall graft survival rates. To address these concerns, a comprehensive study must be conducted that examines the clinical, microbiological, and procedural factors influencing the success of TPK.

Hence, we aim to investigate the clinical and microbiological factors that influence the success of therapeutic keratoplasty in managing advanced microbial keratitis, focusing on identifying the risk factors for graft infection and addressing the existing gaps in postoperative care and donor material quality.

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

  • a)Non healing microbial keratitis bacterial fungal or parasitic unresponsive to standard medical therapy for 2 weeks or earlier in case of advanced ulcer b)Corneal perforation of more than 2mm in size due to infectious cause c)Descemetocele leading to impending perforation of the cornea d)Advanced corneal ulcers size of more than 5mm and involving the posterior two thirds of the corneal stroma.

排除标准

  • a)Patients with viral keratitis b)Cases where the primary diagnosis is not microbial keratitis c)Infectious infiltration involving the limbus or sclera d)Patients with a history of corneal surgery within the 12 months preceding the study.

研究者

发起方
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tejaswi Prasad P V

Aravind Eye Hospital and Postgraduate Institute of Ophthalmology

研究点 (1)

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