Effect of Nursing Care on Prevention of Dry Eye

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

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.

Study Overview

• Status: Unknown
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: LACRIBELL®; Device: VIDISIC® GEL

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Montes Claros, Minas Gerais, Brazil, 39402-218
      • Recruiting
      • Santa de Misericórdia Montes Claros
      • Contact: Diego Dias de Araújo; Phone Number: (38)3213-2150; Email: diego.dias1508@gmail.com
      • Principal Investigator: Diego Dias de Araújo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Diego Dias de Araújo
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; State University of Montes Claros
• Investigators: Principal Investigator: Diego D Araújo, PhD student, State University of Montes Claros, Minas Gerais, Brazil

Publications and helpful links

General Publications

• de Araujo DD, Almeida NG, Silva PM, Ribeiro NS, Werli-Alvarenga A, Chianca TC. Prediction of risk and incidence of dry eye in critical patients. Rev Lat Am Enfermagem. 2016;24:e2689. doi: 10.1590/1518-8345.0897.2689. Epub 2016 May 17.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Dry eye; Diseases of the eye and adnexa
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: EE/UFMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.