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

Corneal Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03762889
• Other study ID #: 20180875
• Status: Withdrawn
• Phase: N/A
• Start date: June 2019
• Est. completion date: December 2019

Study information

• Verified date: June 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Injuries
• Wounds and Injuries

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

White E, Crosse MM. The aetiology and prevention of peri-operative corneal abrasions. Anaesthesia. 1998 Feb;53(2):157-61. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability Scale Per Operator	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.	This measure will be evaluated up to 6 months after the post-surgical operation.
Primary	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.
Primary	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	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.	This measure will be evaluated up to 48 hours post-surgical operation.
Secondary	Incidence of Nightmare during Use	Patient's report of experiencing nightmares during the surgery will be recorded qualitatively.	This measure will be evaluated up to 48 hours post-surgical operation.

External Links

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