A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries Related to Exposure in Patients Admitted to the General Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Presence or absence of corneal damage
研究概览
简要总结
Study Rationale:
The insertion of a bandage contact lens or punctal plug in a defined group of patients admitted to the ICU may be more effective than standard care in decreasing the incidence of corneal injuries.
Study Objectives:
- To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
- To assess the safety of a contact bandage lens and punctal plug in critically ill patients.
详细描述
This is a prospective, randomized study
Study Population:
Consecutive patients admitted to the General Intensive Care Unit of the Rabin Medical Center and Sharon Hospital Medical Center over a 6-month period who meet criteria for inclusion.
Procedures:
Consecutive patients meeting inclusion criteria will be enrolled in the study. Patients will be randomized to 3 groups: the bandage contact lens group, who will be assigned to insertion of a bandage contact lens; the punctal plug group, who will be assigned to the insertion of punctal plugs; and the control group, who will be assigned to standard eye care as currently practiced in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be > 18 years of age. Patients who meet the following criteria will be considered eligible for the study: i) require mechanical ventilation; ii) require continuous infusion of sedative medication with or without neuromuscular paralysis; iii) anticipated ICU stay > 5 days.
排除标准
- •Patients will be excluded if there is any preexisting corneal disease or an ophthalmic injury related to the present admission (e.g. ophthalmic trauma) to the ICU.
研究组 & 干预措施
bandage contact lens
A bandage contact lens will be inserted by a physician from the ophthalmology department within the first 24 hours of admission of the patient to the ICU. The position of the lens will be confirmed. The lens will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit.
干预措施: contact lens (Device)
punctal plug
A punctal plug (Painless Silicon Plugs),will be inserted into each eye. Lubricant drops will be instilled four times daily into each eye. The punctal plug will remain in- situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit at which time it will be removed by a physician from the ophthalmology department.
干预措施: punctal plug (Device)
Control group
Hydroxyethylcellulose drops will be inserted into each eye four times a day and erythromycin ophthalmic ointment will be applied three times a day as well.
结局指标
主要结局
Presence or absence of corneal damage
时间窗: From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months.
To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
次要结局
- Presence of infection(From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months)
研究者
jonatan cohen
Prof.Jonathan Cohen
Rabin Medical Center