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Effect of Nursing Care on Prevention of Dry Eye

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ClinicalTrials.gov Identifier: NCT02767258
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
State University of Montes Claros
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Diego Dias de Araújo, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: LACRIBELL® Device: VIDISIC® GEL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2019

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 Name: artificial tear gel




Primary Outcome Measures :
  1. Dry Eye [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767258


Contacts
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Contact: Diego D Araújo, PhD student 55 (38) 3213 2150 ext Brazil diego.dias1508@gmail.com
Contact: Tânia CM Chianca, PhD 55 (31) 3409 9887 ext Brazil taniachianca@gmail.com

Locations
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Brazil
Santa de Misericórdia Montes Claros Recruiting
Montes Claros, Minas Gerais, Brazil, 39402-218
Contact: Diego Dias de Araújo    (38)3213-2150    diego.dias1508@gmail.com   
Principal Investigator: Diego Dias de Araújo         
Sponsors and Collaborators
Diego Dias de Araújo
State University of Montes Claros
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Diego D Araújo, PhD student State University of Montes Claros, Minas Gerais, Brazil

Publications:
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Responsible Party: Diego Dias de Araújo, Teacher and Student Doctoral Nursing, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02767258     History of Changes
Other Study ID Numbers: EE/UFMG
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Diego Dias de Araújo, Federal University of Minas Gerais:
Dry eye
Diseases of the eye and adnexa

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions