Effect of Nursing Care on Prevention of Dry Eye

Diego Dias de Araújo

Status: Unknown

Conditions: Dry Eye Syndromes

Treatments: Device: VIDISIC® GEL; Device: LACRIBELL®

Study type: Interventional

Funder types: Other

Identifiers

NCT02767258

EE/UFMG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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%.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Sham Comparator: Eye drop

Active Comparator group

Description:

Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.

Treatment:

Device: LACRIBELL®

VIDISIC® GEL

Experimental group

Description:

Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.

Treatment:

Device: VIDISIC® GEL