A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries

NCT ID: NCT01961193

Last Updated: 2013-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-07-31

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.

Conditions

Contact Lens and Punctal Plug in Preventing Corneal Injuries

Keywords

critically ill patients; punctal plug; corneal injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

contact lens

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

punctal plug

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

punctal 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.

Intervention Type: DEVICE

Other Intervention Names

contact bandage lens; Painless Silicon Plugs

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

jonatan cohen

Prof.Jonathan Cohen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Cohen, MD Prof

Role: PRINCIPAL_INVESTIGATOR

ICU dep't , Rabin MC Campus Beilinson

Locations

Rabin MC Beilinson

Petah Tikva, , Israel

Countries

Israel

Central Contacts

Jonathan Cohen, MD Prof

Role: CONTACT

Phone: 9729376524

Email: jonatanc@clalit.org.il

Milana Grinev, Study Coordinator

Role: CONTACT

Phone: 97239376521

Email: milang@clalit.org.il

Facility Contacts

Jonathan Cohen, MD Professor

Role: primary

Milana Grinev, RN Study Coordinator

Role: backup

Other Identifiers

7517

Identifier Type: -

Identifier Source: org_study_id