Mayo Clinic
Rochester, Minnesota, 55901, United States
NCT Number: NCT02951351
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55901, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Other names: alcaine
Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
Time frame: pre-injection
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.
Time frame: post-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.
Time frame: post-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.
Time frame: post-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.
Time frame: post-injection
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..
Time frame: post-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 comfortable the subject was with the procedure, the higher the score, the less comfortable the subject was with the procedure.
Time frame: post-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. 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.
Time frame: post-injection
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.
Mayo Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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