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

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ClinicalTrials.gov Identifier: NCT03762889
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Leo Kleyman, University of Miami

Brief 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.

Condition or disease Intervention/treatment Phase
Corneal Injuries Device: Eyeprotx™ General Anesthesia Protective Goggles Device: Eyelid Tape Device: Eye Ointment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this cohort study, 100 preoperative patients from Jackson Memorial Hospital would be randomly assigned based on age, gender, and type of anesthesia to three samples: anesthesia with Eyeprotx™ Goggles, anesthesia with eyelid tape, and anesthesia with ointment application. Analysis of samples will be based on length of procedure, length of preventative measure application, position during operation(supine or prone), and postoperative events. Patient discomfort or pain, eye dryness intensity would be rated on numerical rating scale. Qualitative analysis will include additional comments from patients and the anesthesiologist.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peri-operative Application of EYEPROTX General Anesthesia Protective Goggles as an Effective Modality to Reduce the Incidence of Corneal Injury Post-Intubation.
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eyeprotx™ Group
This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia.
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.

Active Comparator: Eyelid Tape Group
This group of participants will be receiving the eyelid tape as the preventative measure when intubated perioperatively under general anesthesia.
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.

Active Comparator: Eye Ointment Group
This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia.
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.




Primary Outcome Measures :
  1. Changes in Baseline Ocular Condition post-operation [ Time Frame: The patient's initial rating will be recorded a maximum of 24 hours pre-operation and will be reassessed up to 24 hours after the procedure. ]
    Patient will rate eye discomfort, pain, and dryness intensity, each on a numerical rating-scale of 1 to 8, with 1 being complete absence of discomfort, pain, and dryness, and 8 being the most discomfort, pain, and dryness possible, respectively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762889


Contacts
Contact: Adam M Au, DO MD PHD 7864988476 physicians.creek@yahoo.com
Contact: Leo S Kleyman, BS Candidate 9548818801 lxk316@miami.edu

Locations
United States, Florida
Jackson Memorial Hospital Not yet recruiting
Miami, Florida, United States, 33136
Contact: Adam M Au, DO MD PHD    786-498-8476    physicians.creek@yahoo.com   
Sponsors and Collaborators
University of Miami
Investigators
Study Director: Adam M Au, DO MD PHD Jackson Health System

Additional Information:
Publications:
Responsible Party: Leo Kleyman, Research Fellow, University of Miami
ClinicalTrials.gov Identifier: NCT03762889     History of Changes
Other Study ID Numbers: 20180875
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Corneal Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Corneal Diseases
Eye Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs