Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches

Corneal Diseases Clinical Trial

— OCUREA2  

Official title:

Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348242
• Other study ID #: 2014-A01197-40
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: February 10, 2017
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.

This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient

• hospitalized in an intensive care unit

• tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h

Exclusion Criteria:

• Patient currently treated by eyedrops for glaucoma

• antecedent of corneal transplant

• ocular prosthesis

Related Conditions & MeSH terms

• Corneal Diseases

Intervention

Device:
• Aqueous Gel
1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours
• Eyelid Occlusion Dressing
Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily
• Artificial Tears
1 drop of Phylarm® artificial tears in the eye every 6 hours

Locations

Country	Name	City	State
France	Fondation ophtalmologique Adolphe de Rothschild	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)		participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week