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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

Page last updated: August 23, 2015

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