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Completed

NCT Number: NCT02293876

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

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

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Key information

Age range

18 year–93 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Risoleta Tolentino Neves

Belo Horizonte, Minas Gerais, 31744012, Brazil

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LACRIBELL®

Device

Hypromellose and dextran based eyedrop, used in the treatment of dry eye.

Other names: Eyedrop

LIPOSIC®

Device

Carbomer and Sorbitol based gel, used in the treatment of dry eye.

Other names: Occular Gel

Glad wrap

Device

A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.

Other names: Polyethylene film

Primary outcomes

  1. Keratitis

    Time frame: Five days

    Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

Sponsors and collaborators

Lead sponsor

Hospital Risoleta Tolentino Neves

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Official study title

Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial

Acronym: CORNEALPREV

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2014
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.