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

Contact Lens and Punctal Plug in Preventing Corneal Injuries Clinical Trial

— COMLENPLSTAN  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01961193
• Other study ID #: 7517
• Status: Not yet recruiting
• Phase: N/A
• First received: October 1, 2013
• Last updated: October 10, 2013
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: October 2013
• Source: Rabin Medical Center
• Contact: Jonathan Cohen, MD Prof
• Phone: 9729376524
• Email: jonatanc[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contact Lens and Punctal Plug in Preventing Corneal Injuries

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Rabin MC Beilinson	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of corneal damage	To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.	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.	Yes
Secondary	Presence of infection	Results of bacterial cultures	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	No