Effect of Nursing Care on Prevention of Dry Eye

Study Overview
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Brief Summary
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Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.

Detailed Description
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Critically ill patients are at higher risk for dry eye and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.

Official Title
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Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: LACRIBELL®
* Device: VIDISIC® GEL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be over 18 years; Did not present dry eye at the time of admission; Stay in the ICU for at least 24 hours; Be in mechanical ventilation therapy; Glance less than 5 per minute; Comatose, sedated or Glasgow less than or equal to 7; Consent to participate in research or have. Exclusion Criteria: Have not the responsabille authorization; Patients with severe eye disease or with history of adverse effects after use of any of the interventions proposed and not tolerate the treatment: artificial tear gel, artificial tear liquid and saline 0.9%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sham Comparator: Eye drop<br>Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing. | Device: LACRIBELL®<br>* Hypromellose and dextran based eyedrop, used in the treatment of dry eye.<br>* Other names: eyedrop;|
| Experimental: VIDISIC® GEL<br>Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border. | Device: VIDISIC® GEL<br>* Carbomer based gel, used in the treatment of dry eye.<br>* Other names: artificial tear gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye | Interventions will be applied in both eyes of the patients from 12 to 12 hours for five consecutive days. Schirmer test will be applyed to evaluate the lacrimal volume. Fluorescein test will be applyed to evaluate the ocular surface. | Five consecutive days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Diseases of the eye and adnexa