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Corneal Lesions in Intensive Care Unit (ICU) Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center (CORNEALPREV)

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ClinicalTrials.gov Identifier: NCT02293876
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : November 19, 2014
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Andreza Werli Alvarenga, Hospital Risoleta Tolentino Neves

Brief Summary:
The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.

Condition or disease Intervention/treatment Phase
Keratitis Corneal Ulcer Device: LACRIBELL® Device: LIPOSIC® Device: Glad wrap Not Applicable

Detailed Description:
Critically ill patients are at higher risk for corneal injury 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. There is a scale for assessing the risk for corneal injury. Thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. The specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. Patients and methods: This study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Eye drop
Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing.
Device: LACRIBELL®
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
Other Name: Eyedrop

Sham Comparator: Ocular gel
Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border.
Device: LIPOSIC®
Carbomer and Sorbitol based gel, used in the treatment of dry eye.
Other Name: Occular Gel

Sham Comparator: Glad wrap
Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber.
Device: Glad wrap
A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.
Other Name: Polyethylene film

No Intervention: Control group
Ocular cleansing three times a day.



Primary Outcome Measures :
  1. Keratitis [ Time Frame: Five days ]
    Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.



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Ages Eligible for Study:   18 Years to 93 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ramsay sedation scale 5 or 6
  • Glasgow coma scale lower than 7
  • Use of oxygen therapy by facial device above 6 liters per minute or mechanical ventilation
  • Blink reflex less than 5 times per minute or ocular globe exposure

Exclusion Criteria:

  • Less than 48 hours in Intensive Care Unit

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): NCT02293876


Locations
Brazil
Hospital Risoleta Tolentino Neves
Belo Horizonte, Minas Gerais, Brazil, 31744012
Sponsors and Collaborators
Hospital Risoleta Tolentino Neves
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators
Principal Investigator: Andreza Werli-Alvarenga, RN, MD, PhD Hospital Risoleta Tolentino Neves

Responsible Party: Andreza Werli Alvarenga, RN, MD, PhD, Hospital Risoleta Tolentino Neves
ClinicalTrials.gov Identifier: NCT02293876     History of Changes
Other Study ID Numbers: ICU CORNEAL ULCER 01
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Andreza Werli Alvarenga, Hospital Risoleta Tolentino Neves:
Corneal Diseases
Corneal Ulcer
Nursing Diagnosis
Intensive Care Units
Nursing
Randomized Clinical Trial

Additional relevant MeSH terms:
Keratitis
Corneal Ulcer
Corneal Diseases
Eye Diseases
Eye Infections
Infection
Ophthalmic Solutions
Pharmaceutical Solutions