A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contact Lens and Punctal Plug in Preventing Corneal Injuries
Intervention: contact lens (Device); punctal plug (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Rabin Medical Center Official(s) and/or principal investigator(s): Jonathan Cohen, MD Prof, Principal Investigator, Affiliation: ICU dep't , Rabin MC Campus Beilinson
Overall contact: Jonathan Cohen, MD Prof, Phone: 9729376524, Email: jonatanc@clalit.org.il
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Presence or absence of corneal damage
Secondary outcome: Presence of infection
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jonathan Cohen, MD Prof, Phone: 9729376524, Email: jonatanc@clalit.org.il
Rabin MC Beilinson, Petah Tikva 49100, Israel; Not yet recruiting Jonathan Cohen, MD Professor, Phone: 97239376524, Email: jonatanc@gmail.com Milana Grinev, RN Study Coordinator, Phone: 97239376521, Email: milang@clalit.org.il Pierre Singer, MD, Prof, Sub-Investigator Jonathan Cohen, MD Prof, Principal Investigator Shaul Lev, MD, Sub-Investigator Milana Grinev, RN, Sub-Investigator Inbal Avisar, MD, Sub-Investigator
Additional Information
Starting date: May 2015
Last updated: October 10, 2013
|