Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

Study Overview
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Brief Summary
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The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.

Detailed Description
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To ensure the extra drop does not interfere with antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal injection before and after the application of the extra eye drop. Patients will be randomized to undergo additional topical analgesia during intravitreal injection vs. the standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the additional topical analgesia does not interfere with antisepsis.

Official Title
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Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

Conditions
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Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site, Injection Site Infection, Pain, Postoperative

Intervention / Treatment
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* Drug: Proparacaine
* Procedure: Conjunctival culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing intravitreal injection who do not have active eye infections greater than 18 years of age Exclusion Criteria: patients younger than 18 years of age patients with active eye infections

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard procedure + Culture<br>Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed. | Procedure: Conjunctival culture<br>* Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.<br>|
| Experimental: Proparacaine + Culture<br>Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed. | Drug: Proparacaine<br>* Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.<br>* Other names: alcaine;Procedure: Conjunctival culture<br>* Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study Participants With Positive Conjunctival Culture | Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew. | pre-injection | 
| Pain at the Time of Injection | Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain. | post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Pain From Intravitreal Injection | Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the residual pain, the higher the score, the higher the residual pain. | post-injection | 
| Overall Impression of Visit for Intravitreal Injection | Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the visit, the higher the score, the less positive impression of the visit. | post-injection | 
| Impression of Pre-injection Preparations | Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey consisted of 6 questions and was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the preparation process, the higher the score, the less positive impression of the preparation process.. | post-injection | 
| Comfort With Intravitreal Injection Standard Procedure | Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more comfortable the subject was with the procedure, the higher the score, the less comfortable the subject was with the procedure. | post-injection | 
| Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health | Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. A lower score indicated subjects did not expect the injection would negatively affect their overall health. Higher scores indicated subjects expected the injection would negatively affect their overall health. | post-injection | 
| Expectation the Injection Will Contribute to Curing/Improving Eye Condition | Patients were asked to rate their expectation on the extent to which the intravitreal injections would contribute to curing or improving their eye condition. The question was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a negative response (not at all) and 10 was a positive response (to a large extent). A low score indicated the subject did not expect the injection would contribute to curing or improving the eye condition while a high score indicated the subject did expect the injection will help to cure or improve the eye condition. | post-injection |