Contact Lens and Punctal Plug in Preventing Corneal Injuries Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention