跳至主要内容
临床试验/CTRI/2024/03/063972
CTRI/2024/03/063972已完成1/2 期

A comparative study of efficacy of prophylactic use of lubricating eye ointment, eye taping and their combination in preventing exposure keratopathy in critically ill patients: A pilot study

BLDE University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Grading of corneal exposure status

研究概览

简要总结

The study aims to compare the effectiveness of prophylactic measures, including lubricating eye ointment, eye taping, and their combination, in preventing exposure keratopathy among critically ill patients. With a lack of such studies in the Indian population, this research becomes essential. Existing literature suggests promising results from interventions like passive blinking, carbomer eye drops, and polyethene covers. The study involves a prospective interventional approach over a year, focusing on patients in critical care units. Patients would be allocated into three groups, with ten patients in each group, using simple random sampling by the chit method. Double blinding would be followed as neither the patient nor the investigator giving the treatment is allocating the groups. Group A patients would receive eyelid taping; Group B patients would receive 2% hydroxypropyl methylcellulose eye ointment; and Group C patients would receive eyelid taping and 2% hydroxypropyl methylcellulose eye ointment. Ocular examination has to be done along with examination with fluorescein dye. Patients would be graded using following grading system to track progression of disease and its response to treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients above 18 years of age admitted in critical care unit with impaired blink reflex.

排除标准

  • History of ophthalmic disease or eye surgery
  • History of injury preventing the eyelids from closing.
  • Previous ICU admissions in the past month.
  • Patients positive for the fluorescein test.

结局指标

主要结局

Grading of corneal exposure status

时间窗: Daily till discharge

次要结局

  • appearance of any corneal opacification(Daily evaluation till discharge of the patient from critical care units)

研究者

发起方
BLDE University
申办方类型
Other [Deemed to be University]
责任方
Principal Investigator
主要研究者

Dr Keerti Wali

Shri B.M. Patil Medical College, Vijayapura, Karnataka

研究点 (1)

Loading locations...

相似试验