Tegaderm vs. EyeGard for Eye Protection

Study Overview
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Brief Summary
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This study compares TegadermTM and EyeGard® in general anesthesia.

Detailed Description
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Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.

Official Title
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A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia

Conditions
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Erythema

Intervention / Treatment
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* Device: Medical tapes: TegadermTM and EyeGard®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Surgeries scheduled for anesthesia of any duration Exclusion Criteria: Any patient that does not consent Any patient who has: Pre-existing eyelid erythema or other eyelid trauma Eyelid piercings Any surgery on the head, brain, neck, teeth, mouth, eyes or face Surgery in the prone position Patients <18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Every patient will have each tape on each eye -EyeGard® on one eye and the TegadermTM on the other eye according to the randomization schema.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TegadermTM on R eye, EyeGard® on L eye<br>Patients will get TegadermTM on Right eye, EyeGard® on Left eye | Device: Medical tapes: TegadermTM and EyeGard®<br>* TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.<br>|
| Experimental: TegadermTM on L eye, EyeGard® on R eye<br>Patients will get TegadermTM on Left eye, EyeGard® on Right eye | Device: Medical tapes: TegadermTM and EyeGard®<br>* TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Eyelid Erythema | The amount of erythema caused upon removal of the tape is the primary outcome of interest. Investigators will use the following 0-3 tape-associated skin index grading scale to grade eyelid erythema: 0- no erythema mild erythema moderate erythema severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis. | Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient Satisfaction will be based on one question and graded on a Likert Scale from 1-5. A score of 5 is considered better (higher satisfaction), while a 1 is considered lower. There are no subscales. | post-operation | 
| Rate of Corneal Abrasions | Corneal abrasion is assessed in the recovery room | post-operation |