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

NCT03762889 | Withdrawn FDA Device

• 1 other identifier: 20180875
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Injuries

Outcome Measures

Primary Outcomes (2)

• Changes in Baseline Ocular Condition post-operatively

  The following will be measured upon evaluation, using a numerical scale of 1 to 8, with 1 being complete absence of condition and 8 being the most severe presentation of the condition: 1\. eye discomfort, 2, pain, and 3. dryness intensity, each on a numerical rating-scale of 1 to 8, The measures will be compared among the goggle, ointment, and tape groups.

  The patient's initial rating will be recorded approximately ten minutes before surgery at the point of anesthesia evaluation and will be reassessed up to 24 hours post-operatively.

• Incidence of Ocular Complications post-operation

  Incidence of corneal abrasion, conjunctivitis, MRSA infection, and direct ocular trauma will be assessed by the anesthesiologist or nurse anesthetist and will be recorded upon diagnosis of condition for all groups.

  Evaluation of these complications will be done from the point the patient has returned to the recovery room to up to one week post-surgery or until discharge, whichever comes first.

Secondary Outcomes (2)

• Patient Awareness during Anesthesia

  This measure will be evaluated up to 48 hours post-surgical operation.

• Incidence of Nightmare during Use

  This measure will be evaluated up to 48 hours post-surgical operation.

Other Outcomes (1)

• Usability Scale Per Operator

  This measure will be evaluated up to 6 months after the post-surgical operation.

Study Arms (3)

Eyeprotx™ Group

EXPERIMENTAL

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

Device: Eyeprotx™ General Anesthesia Protective Goggles

Eyelid Tape Group

ACTIVE COMPARATOR

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

Device: Eyelid Tape

Eye Ointment Group

ACTIVE COMPARATOR

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

Device: Eye Ointment

Interventions

Eyeprotx™ General Anesthesia Protective Goggles DEVICE

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.

Eyeprotx™ Group

Eyelid Tape DEVICE

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.

Eyelid Tape Group

Eye Ointment DEVICE

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.

Eye Ointment Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Related Publications (3)

• Gild WM, Posner KL, Caplan RA, Cheney FW. Eye injuries associated with anesthesia. A closed claims analysis. Anesthesiology. 1992 Feb;76(2):204-8. doi: 10.1097/00000542-199202000-00008.

  PMID: 1736697 BACKGROUND

• Figueiro MG, Rea MS. Preliminary evidence that light through the eyelids can suppress melatonin and phase shift dim light melatonin onset. BMC Res Notes. 2012 May 7;5:221. doi: 10.1186/1756-0500-5-221.

  PMID: 22564396 BACKGROUND

• White E, Crosse MM. The aetiology and prevention of peri-operative corneal abrasions. Anaesthesia. 1998 Feb;53(2):157-61. doi: 10.1046/j.1365-2044.1998.00269.x.

  PMID: 9534639 BACKGROUND

Related Links

• "Corneal Injuries During General Anesthesia", Snow et al

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Adam M Au, DO MD PHD

  Jackson Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 4, 2018
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)