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

Primary Purpose

Corneal Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eyeprotx™ General Anesthesia Protective Goggles
Eyelid Tape
Eye Ointment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corneal Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Jackson Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Eyeprotx™ Group

Eyelid Tape Group

Eye Ointment Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Patient Awareness during Anesthesia
Patient awareness of being under anesthesia will be recorded qualitatively, with accounts of anxiety and/or fear being noted, if applicable.
Incidence of Nightmare during Use
Patient's report of experiencing nightmares during the surgery will be recorded qualitatively.

Full Information

First Posted
November 20, 2018
Last Updated
June 4, 2019
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03762889
Brief Title
Peri-operative Application of Eyeprotx General Anesthesia Goggles As Prevention Against Corneal Injury Post Intubation.
Official Title
Peri-operative Application of EYEPROTX General Anesthesia Protective Goggles as an Effective Modality to Reduce the Incidence of Corneal Injury Post-Intubation.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Trial no longer occurring.
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eyeprotx™ Group
Arm Type
Experimental
Arm Description
This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia.
Arm Title
Eyelid Tape Group
Arm Type
Active Comparator
Arm Description
This group of participants will be receiving the eyelid tape as the preventative measure when intubated perioperatively under general anesthesia.
Arm Title
Eye Ointment Group
Arm Type
Active Comparator
Arm Description
This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia.
Intervention Type
Device
Intervention Name(s)
Eyeprotx™ General Anesthesia Protective Goggles
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Eyelid Tape
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Eye Ointment
Intervention Description
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 Measure Information:
Title
Changes in Baseline Ocular Condition post-operatively
Description
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.
Time Frame
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.
Title
Incidence of Ocular Complications post-operation
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Patient Awareness during Anesthesia
Description
Patient awareness of being under anesthesia will be recorded qualitatively, with accounts of anxiety and/or fear being noted, if applicable.
Time Frame
This measure will be evaluated up to 48 hours post-surgical operation.
Title
Incidence of Nightmare during Use
Description
Patient's report of experiencing nightmares during the surgery will be recorded qualitatively.
Time Frame
This measure will be evaluated up to 48 hours post-surgical operation.
Other Pre-specified Outcome Measures:
Title
Usability Scale Per Operator
Description
The anesthesiologists and nurse anesthetists working on the trial will be asked to complete a usability scale questionnaire to evaluate the effectiveness of the different variation of the goggles, such as goggles with a strap versus goggles with short sterilized adhesive tape.
Time Frame
This measure will be evaluated up to 6 months after the post-surgical operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam M Au, DO MD PHD
Organizational Affiliation
Jackson Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
1736697
Citation
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.
Results Reference
background
PubMed Identifier
22564396
Citation
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.
Results Reference
background
PubMed Identifier
9534639
Citation
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.
Results Reference
background
Links:
URL
https://journals.lww.com/anesthesia-analgesia/Abstract/1975/07000/Corneal_Injuries_During_General_Anesthesia.14.aspx
Description
"Corneal Injuries During General Anesthesia", Snow et al

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

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