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

Not Applicable

• Conditions: Contact Lens and Punctal Plug in Preventing Corneal Injuries

• Registration Number: NCT01961193
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-10
• Last Update Submitted: 2013-10-10
• Study First Posted: 2013-10-11
• Last Update Posted: 2013-10-11
• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rabin MC Beilinson; 🇮🇱 Petah Tikva, Israel