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

NCT02348242 | Completed

• 1 other identifier: 2014-A01197-40
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Diseases

Keywords

Intensive care; corneal damage; prevention; nursing protocol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Aqueous gel

EXPERIMENTAL

In the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator)

Device: Aqueous Gel; Device: Artificial Tears

Eyelid occlusion dressing

EXPERIMENTAL

In the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator)

Device: Eyelid Occlusion Dressing; Device: Artificial Tears

Interventions

Aqueous Gel DEVICE

1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours

Also known as: Dexpanthenol® 0.2%

Aqueous gel

Eyelid Occlusion Dressing DEVICE

Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily

Also known as: Pro-Ophta® Dressing

Eyelid occlusion dressing

Artificial Tears DEVICE

1 drop of Phylarm® artificial tears in the eye every 6 hours

Also known as: Phylarm®

Aqueous gel; Eyelid occlusion dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient currently treated by eyedrops for glaucoma
• antecedent of corneal transplant
• ocular prosthesis

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Corneal Diseases; Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Jean-Michel DEVYS, Dr

  Fondation Ophtalomologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 28, 2015
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

FR (1)