A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries

NCT01961193 | Unknown DMC

• 1 other identifier: 7517
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Study Rationale: The insertion of a bandage contact lens or punctal plug in a defined group of patients admitted to the ICU may be more effective than standard care in decreasing the incidence of corneal injuries. Study Objectives:

1. 1.To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
2. 2.To assess the safety of a contact bandage lens and punctal plug in critically ill patients.

Conditions

Contact Lens and Punctal Plug in Preventing Corneal Injuries

Keywords

critically ill patients; punctal plug; corneal injuries

Outcome Measures

Primary Outcomes (1)

• Presence or absence of corneal damage

  To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.

  From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months.

Secondary Outcomes (1)

• Presence of infection

  From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months

Study Arms (3)

bandage contact lens

EXPERIMENTAL

A bandage contact lens will be inserted by a physician from the ophthalmology department within the first 24 hours of admission of the patient to the ICU. The position of the lens will be confirmed. The lens will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit.

Device: contact lens

punctal plug

EXPERIMENTAL

A punctal plug (Painless Silicon Plugs),will be inserted into each eye. Lubricant drops will be instilled four times daily into each eye. The punctal plug will remain in- situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit at which time it will be removed by a physician from the ophthalmology department.

Device: punctal plug

Control group

NO INTERVENTION

Hydroxyethylcellulose drops will be inserted into each eye four times a day and erythromycin ophthalmic ointment will be applied three times a day as well.

Interventions

contact lens DEVICE

A bandage contact lens will be inserted by a physician from the ophthalmology department within the first 24 hours of admission of the patient to the ICU. The position of the lens will be confirmed. The lens will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit.

Also known as: contact bandage lens

bandage contact lens

punctal plug DEVICE

A punctal plug will be inserted into each eye. Lubricant drops ethylcellulose) will be instilled four times daily into each eye. The punctal plug will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit at which time it will be removed by a physician from the ophthalmology department.

Also known as: Painless Silicon Plugs

punctal plug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients must be \> 18 years of age. Patients who meet the following criteria will be considered eligible for the study: i) require mechanical ventilation; ii) require continuous infusion of sedative medication with or without neuromuscular paralysis; iii) anticipated ICU stay \> 5 days.

You may not qualify if:

• \- Patients will be excluded if there is any preexisting corneal disease or an ophthalmic injury related to the present admission (e.g. ophthalmic trauma) to the ICU.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin MC Beilinson

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Corneal Injuries

Interventions

Contact Lenses; Punctal Plugs

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Officials

• Jonathan Cohen, MD Prof

  ICU dep't , Rabin MC Campus Beilinson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Cohen, MD Prof

CONTACT

9729376524; jonatanc@clalit.org.il

Milana Grinev, Study Coordinator

CONTACT

97239376521; milang@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Jonathan Cohen

Study Record Dates

• First Submitted: October 1, 2013
• First Posted: October 11, 2013
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

IL (1)