NCT03762889

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

Peri-operative Application of EYEPROTX General Anesthesia Protective Goggles as an Effective Modality to Reduce the Incidence of Corneal Injury Post-Intubation.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Corneal Injuries

Interventions

Type	Name	Description
DEVICE	Eyeprotx™ General Anesthesia Protective Goggles	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. The integral function is to reduce intraocular pressure while in place, prevent operating room bright light penetration, facilitate a swift placement preventative measure with straps, form a barrier against bacterial invasion and mechanical damage. This study would seek to examine this goggles' effectiveness as a preventative measure as vs. other measures.
DEVICE	Eyelid Tape	Taping the eyelids during intubation is one of the standard techniques used perioperatively under general anesthesia. This intervention would be used for the Eyelid Tape Group.
DEVICE	Eye Ointment	Another standard technique used perioperatively under general anesthesia is to apply an ointment to the eye for lubrication. This intervention would be applied to the Eye Ointment Group.

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-12-04
• Last updated: 2019-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study