Clinical trial NCT01961193: A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contact Lens and Punctal Plug in Preventing Corneal Injuries
Keywords: critically ill patients
punctal plug
corneal injuries
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence or absence of corneal damage
timeFrame: 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.
Secondary outcomes:
measure: Presence of infection
timeFrame: 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
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin MC Beilinson
Study officials:
affiliation: ICU dep't , Rabin MC Campus Beilinson
name: Jonathan Cohen, MD Prof
role: PRINCIPAL_INVESTIGATOR
References: