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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
jonatan cohen, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01961193
First received: October 1, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention
Contact Lens and Punctal Plug in Preventing Corneal Injuries
Device: contact lens
Device: punctal plug

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Presence or absence of corneal damage [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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:
  • Presence of infection [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Results of bacterial cultures


Estimated Enrollment: 105
Study Start Date: May 2015
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: contact bandage lens
Experimental: 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.
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.
Other Name: Painless Silicon Plugs
No Intervention: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961193

Contacts
Contact: Jonathan Cohen, MD Prof 9729376524 jonatanc@clalit.org.il
Contact: Milana Grinev, Study Coordinator 97239376521 milang@clalit.org.il

Locations
Israel
Rabin MC Beilinson Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Jonathan Cohen, MD Professor    97239376524    jonatanc@gmail.com   
Contact: Milana Grinev, RN Study Coordinator    97239376521    milang@clalit.org.il   
Sub-Investigator: Pierre Singer, MD, Prof         
Principal Investigator: Jonathan Cohen, MD Prof         
Sub-Investigator: Shaul Lev, MD         
Sub-Investigator: Milana Grinev, RN         
Sub-Investigator: Inbal Avisar, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Jonathan Cohen, MD Prof ICU dep't , Rabin MC Campus Beilinson
  More Information

No publications provided

Responsible Party: jonatan cohen, Prof.Jonathan Cohen, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01961193     History of Changes
Other Study ID Numbers: 7517
Study First Received: October 1, 2013
Last Updated: October 10, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
critically ill patients
punctal plug
corneal injuries

ClinicalTrials.gov processed this record on September 18, 2014