An interventional study of contact lens and punctal plug in Contact Lens and Punctal Plug in Preventing Corneal Injuries, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-11.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Prevention
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:
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.
33 studies on the registry are indexed under Corneal Injuries; 9 are open to participants now.
This study's planned enrollment of 105 is above the median of 43 across 25 interventional studies indexed under Corneal Injuries.
Browse Corneal Injuries studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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- 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.
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 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
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.
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.
Also known as: contact bandage lens
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.
Also known as: Painless Silicon Plugs
Presence or absence of corneal damage
To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
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.
Presence of infection
Results of bacterial cultures
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
The record gives a start of May 2015, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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