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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyeprotx™ Group | Experimental | This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia. |
|
| 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. |
|
| Eye Ointment Group | Active Comparator | This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Incidence of Nightmare during Use |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam M Au, DO MD PHD | Jackson Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1736697 | Background | 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. | |
| 22564396 | 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. |
| Label | URL |
|---|---|
| "Corneal Injuries During General Anesthesia", Snow et al | View source |
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| ID | Term |
|---|---|
| D065306 | Corneal Injuries |
| ID | Term |
|---|---|
| D005131 | Eye Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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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.
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| 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. |
|
| 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. |
|
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. |
| 9534639 | 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. |
| D009422 |
| Nervous System Diseases |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |