Effect of Nursing Care on Prevention of Dry Eye

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02767258
• Other study ID #: EE/UFMG
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2016
• Last updated: February 13, 2017
• Start date: May 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2017
• Source: Federal University of Minas Gerais
• Contact: Diego D Araújo, PhD student
• Phone: 55 (38) 3213 2150
• Email: diego.dias1508[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• LACRIBELL®
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
• VIDISIC® GEL
Carbomer based gel, used in the treatment of dry eye.

Locations

Country	Name	City	State
Brazil	Santa de Misericórdia Montes Claros	Montes Claros	Minas Gerais

Sponsors (3)

Lead Sponsor	Collaborator
Diego Dias de Araújo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, State University of Montes Claros

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

de Araújo 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. English, Portuguese, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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