Clinical Trial: A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
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 Inten
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:
- To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
- To assess the safety of a contact bandage lens and punctal plug in critically ill patients.
Detailed Summary:
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.
Sponsor: Rabin Medical Center
Current Primary Outcome: 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: October 1, 2013
Date Started: May 2015
Date Completion: July 2015
Last Updated: October 10, 2013
Last Verified: October 2013