| Primary | 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. | | Posted | | Count of Participants | | Participants | | pre-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Wilcoxon (Mann-Whitney) | | 0.28 | | | | | | | | | | | | | | Non-Inferiority | By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin. | |
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| Primary | 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. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| Secondary | 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. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| Secondary | 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. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| Secondary | 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.. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| Secondary | 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. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| Secondary | 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. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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| Secondary | 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. | | Posted | | Median | Full Range | score on a scale | | post-injection | | | | ID | Title | Description |
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| OG000 | Standard Procedure + Culture | 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. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | | OG001 | Proparacaine + Culture | 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. Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. |
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