Clinical trial NCT03762889: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Corneal Injuries
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Baseline Ocular Condition post-operatively
timeFrame: 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.
measure: Incidence of Ocular Complications post-operation
timeFrame: 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:
measure: Patient Awareness during Anesthesia
timeFrame: This measure will be evaluated up to 48 hours post-surgical operation.
measure: Incidence of Nightmare during Use
timeFrame: This measure will be evaluated up to 48 hours post-surgical operation.
Other outcomes:
measure: Usability Scale Per Operator
timeFrame: This measure will be evaluated up to 6 months after the post-surgical operation.
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: Jackson Health System
name: Adam M Au, DO MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.