Effect of Nursing Care on Prevention of Dry Eye

Not Applicable

• Conditions: Dry Eye Syndromes
• Interventions: Device: LACRIBELL®; Device: VIDISIC® GEL

• Registration Number: NCT02767258
• Lead Sponsor: Diego Dias de Araújo

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14
• Primary Completion: 2017-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator: Eye drop	LACRIBELL®	Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.
VIDISIC® GEL	VIDISIC® GEL	Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.

Primary Outcome Measures

Name	Time	Method
Dry Eye	Five consecutive days	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.

Trial Locations

Locations (1)

Santa de Misericórdia Montes Claros; 🇧🇷 Montes Claros, Minas Gerais, Brazil