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临床试验/CTRI/2025/07/090777
CTRI/2025/07/090777尚未招募不适用

Assessment Of Risk Factors and Outcomes of Posterior Segment Complications Following Therapeutic Penetrating Keratoplasty- A Prospective Cohort Study

Aravind Eye Hospital, Pondicherry1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
246
试验地点
1
主要终点
To analyse the incidence of posterior segment complications following Therapeutic penetrating keratoplasty

研究概览

简要总结

Therapeutic penetrating keratoplasty (TPK) is a surgical intervention performed to eliminate infection when medical treatment fails, primarily in cases of fungal keratitis. Corneal transplantation can be either full-thickness (penetrating keratoplasty) or partial-thickness (lamellar keratoplasty), with penetrating keratoplasty serving various purposes, including tectonic, therapeutic, cosmetic, and optical restoration. Corneal blindness affects approximately 1.5 to 2 million individuals annually, with corneal opacity accounting for 7.4% of blindness among individuals aged greater than  or equal to 50 years and 37.5 percent in those aged 0-49 years in India. Late diagnosis and delayed treatment frequently necessitate emergency TPK, which carries risks of intraoperative complications, including intraocular infection spread and expulsive choroidal hemorrhage, along with postoperative complications such as glaucoma, graft failure, retinal detachment, recurrent infection, and increased intraocular pressure. This study aims to analyze the incidence of posterior segment complications following TPK and identify associated risk factors. Patients aged 18 years and above undergoing TPK at Aravind Eye Hospital, Pondicherry, will be enrolled after providing written informed consent, while those with pre-existing posterior segment conditions will be excluded. Preoperative data collection will encompass demographic details, disease duration, keratitis type, prior keratoplasty history, visual acuity, intraocular pressure, and other infection-related parameters. Before surgery, patients will receive an intravenous infusion of 20% Mannitol (100 ml), followed by local anesthesia using facial and peribulbar blocks. The surgical procedure will be performed under continuous monitoring, with documentation of anesthesia details, intraoperative sedation, complications, and surgeon expertise. Postoperative assessments will take place on the 1st, 10th, 30th, and 90th days, covering parameters such as visual acuity, intraocular pressure, graft clarity, wound integrity, suture status, infection persistence, and posterior chamber complications. Additionally, information on resurgeries will be collected, noting the type and reasons. The operating surgeon will document details in the study proforma immediately after surgery. Study participants will remain anonymous, and all data will be used solely for academic purposes. This prospective cohort study aims to improve understanding of posterior segment complications following TPK, providing valuable insights to enhance patient outcomes and optimize treatment strategies for better postoperative recovery and complication prevention.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients 18 years and above who will be undergoing Therapeutic penetrating keratoplasty at Aravind Eye Hospital, Pondicherry.

排除标准

  • Patients with pre-existing posterior segment will be excluded.

结局指标

主要结局

To analyse the incidence of posterior segment complications following Therapeutic penetrating keratoplasty

时间窗: At the time of presentation, | Preoperative on the day of surgery, | Intraoperative, | Post operative Day 1, | Post operative Day 10, | Post operative Day 30, | Post operative Day 90.

次要结局

  • To identify the risk factors associated with the development of posterior segment complications post-TPK.(At the time of presentation,)

研究者

发起方
Aravind Eye Hospital, Pondicherry
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Gokulvasanth D

Aravind Eye Hospital, Pondicherry

研究点 (1)

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