Contact Lens and Punctal Plug in Preventing Corneal Injuries
Conditions
Keywords
critically ill patients, punctal plug, corneal injuries
Brief summary
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: 1. To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU. 2. To assess the safety of a contact bandage lens and punctal plug in critically ill patients.
Detailed description
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. In addition, patients in the study will be examined every 4 days by a physician from the ophthalmology department and at either discharge from the ICU or at time of death.
Interventions
DEVICEcontact 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.
DEVICEpunctal plug
A punctal plug will be inserted into each eye. Lubricant drops ethylcellulose) 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.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- 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.
Exclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of corneal damage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Results of bacterial cultures |
Countries
Israel
Contacts
Primary ContactJonathan Cohen, MD Prof
Backup ContactMilana Grinev, Study Coordinator
Outcome results
None listed