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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02293876

Acronym

CORNEALPREV

Enrollment

360

Registered

2014-11-18

Start date

2013-04-30

Completion date

2014-11-30

Last updated

2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Ulcer, Keratitis

Keywords

Corneal Diseases, Corneal Ulcer, Nursing Diagnosis, Intensive Care Units, Nursing, Randomized Clinical Trial

Brief summary

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

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 .

Interventions

DEVICELACRIBELL®

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

DEVICELIPOSIC®

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

DEVICEGlad wrap

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 93 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Keratitis	Five days	Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026