Peri-operative Application of Eyeprotx General Anesthesia Goggles As Prevention Against Corneal Injury Post Intubation.

University of Miami

Status: Withdrawn

Conditions: Corneal Injuries

Treatments: Device: Eyelid Tape; Device: Eye Ointment; Device: Eyeprotx™ General Anesthesia Protective Goggles

Study type: Interventional

Funder types: Other

Identifiers

NCT03762889

20180875

Details and patient eligibility

About

This is a randomized controlled trial that seeks to examine the effectiveness of Eyeprotx™ protective goggles in comparison to traditional methods against ocular injury that can occur perioperatively under general anesthesia.

Full description

Ocular injury is but a devastating condition that can occur perioperatively under general anesthesia. Corneal abrasion is the most common ocular injury during general anesthesia, surpassing case incidence of damage caused by patient movement in ophthalmologic surgery. Causes of ocular injury include corneal drying due to the suppression of tear ducts from anesthetic agents, direct physical trauma, or agitation from the volatile anesthetic used. Ocular injury may also occur due to bacterial infection with MRSA, preventative methods, or rubbing of the eyes postoperatively due to agitation. Agitation may be caused by corneal drying or by shift or disruption in rapid eye movement sleep cycle from light penetration through the eyelids. Attempts at prevention of corneal abrasion have been used, including taping the eyelids shut, manual eye closure, paraffin-based ointment application into the conjunctival sac, and the use of hydrophilic contact lenses, although only a few studies have validated the comparison of these methods' effectiveness.

Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or in any scenario where general anesthesia must be used, such as intubation in an emergency. Current ocular protective measures such as tapes during anesthesia have been associated with injury and infection. With this study, we hope to find a safer preventative technique against ocular injury during the perioperative period.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing general anesthesia
• Patients admitted to Jackson Memorial Hospital

Exclusion criteria

• Patients unable to communicate, for whatever reason
• Patients predisposed to eye conditions
• Patients with history of increased intraocular pressure
• Patients with a medical history of Sicca syndrome
• Patients with claustrophobia
• Patients with pseudoexfoliation syndromes
• Patients with a current exopthalmic condition

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Eyeprotx™ Group

Experimental group

Description:

This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia.

Treatment:

Device: Eyeprotx™ General Anesthesia Protective Goggles

Eyelid Tape Group

Active Comparator group

Description:

This group of participants will be receiving the eyelid tape as the preventative measure when intubated perioperatively under general anesthesia.

Treatment:

Device: Eyelid Tape

Eye Ointment Group

Active Comparator group

Description:

This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia.

Treatment:

Device: Eye Ointment